Reports and downloads
Reports & Downloads
Guidelines & Policies
Our guidelines for ethical, responsible and transparent action.
ESG Management
ESG Management
Sustainability as a goal
Dialog with our stakeholders is immensely important to us. Not only do we want to report transparently on our progress, we also want to learn from our stakeholders.
ESG Management
We want to integrate sustainability into all our business processes, which is why responsibility for all sustainability issues is anchored at the highest level in the Executive Board, and in the Supervisory Board. The ESG team reports directly to our CFO and is in continuous exchange with all relevant business units. Based on relevant data, our internal expertise as well as the dialogue and support from external stakeholders and experts, we implement specific measures in all ESG areas. In this way, we aim to minimise the negative impact of our business activities and strengthen our positive impact.
We want to provide transparent and honest information about our progress and will report on all our material topics in an integrated management report from 2025, in accordance with the CSRD Directive. For an efficient collection, evaluation and reporting of high-quality data, we are also planning to introduce a new ESG software tool in 2025. Our guidelines and the materiality analysis are updated on an annual basis, and the achievement of goals and the implementation of the measures are continuously monitored.
Ratings and initiatives
Since 2019, Formycon is a member of the UN Global Compact , one of the world’s largest and most important initiatives for responsible corporate management, which aims at creating an inclusive and sustainable global economy and which supports companies in aligning their strategies and activities with sustainability goals. In addition to the protection of human rights, the focus is on the elimination of all forms of forced labour, the abolition of child labour, the elimination of discrimination in recruiting and employment, as well as the handling of environmental problems, the observance of precautionary principles, the promotion of environmental awareness and the development and dissemination of environmentally friendly technologies. Formycon is committed to acting responsibly and will continue to drive this commitment forward, now and in the future. By becoming a member of the UN Global Compact, Formycon has committed itself to strategically anchoring the topic of sustainability and contributing to the implementation of the Sustainable Development Goals on the basis of the 10 universal principles. We report annually on our progress in a Communication on Progress (COP) report.
„In my role, I am responsible for developing, implementing and monitoring Formycon’s sustainability strategy. For me, this means bringing people together and enabling the #TeamFormycon to make an important contribution to sustainable management. The open mindedness of the company culture and the very high level of self-motivation of my colleagues spur me on – together we can achieve great things!“
Kristina Modée
Senior Manager Sustainability & ESG
We want to communicate openly and transparently about our topics in the individual ESG areas – the trust of our various stakeholders is immensely important to us. To enable the comparison with other companies and the possibility of tracking our progress, we participate in various ratings. Again, we are working on continuous improvement and take the evaluation as an incentive to strengthen our weaknesses and improve our strengths even further.
ESG Ratings
Social
Social
Diversity, Openness and Social Justice
We are committed to diversity, openness and social justice, not only for our own employees, but along the entire value chain.
Employees
Diversity and Equality
We are #TeamFormycon! Formycon currently employs more than 240 committed employees from over 33 nations, of which around 60% are women. More than 80% of our colleagues work in research and development.
We recognize the power of diversity and promote it wherever we can. We are committed to a world in which every person – regardless of origin, gender, religion or other characteristics – enjoys the same opportunities and rights. Especially in today’s world, we stand by these values, which are essential for us, our company and our future. All our employees are obliged to familiarize themselves with the General Equal Treatment Act (AGG) through appropriate training when they join the company. This training also includes the Formycon Diversity, Equity and Inclusion policy that prohibits discrimination or harassment of any kind in any of our employment practices, including recruitment, hiring, training, promotion or other matters.
We are proud of our organization, which has grown steadily over the years, and the values we live by, openness, tolerance, reliability, appreciation and mutual trust. Since 2022, Formycon is actively supporting the LGBTQIA+ community in the company by establishing special communication channels such as “FOR_MY_Queers_Community”, enabling an exchange on the company’s intranet. A separate LGBTQIA+ podcast series on topics such as diversity or international LGBTQIA+ rights not only provides information, but also sensitizes employees and promotes understanding and tolerance.
Formycon takes the issue of women’s leadership and growth very seriously and strives to provide the work environment to achieve this. The proportion of women at the second management level (Vice President, Senior Director, Director and Associate Director) was 42.9% as of December 31, 2023. At the highest management level (Board of Directors), the proportion was 25%. Altogether, the proportion of women at Formycon across all management positions is 36.2%.
Occupational safety and health
Our employees are at the heart of our success, therefore work safety and the protection of employees are top priorities for Formycon. Operational processes can only run smoothly if health and safety protection is implemented in a practice-oriented way. Formycon holds the “Safe with System” seal of approval from the German employers’ liability insurance association for the raw materials and chemical industry (BG-RCI). As part of the voluntary audit, both the occupational health and safety management system (AMS) and the effectiveness of the occupational health management system (BGM) must be audited, for the seal of approval to be awarded. In addition to the biological safety officer, the project manager in accordance with the German Genetic Engineering Act and the safety specialist, we have entrusted several experienced employees with special tasks in the field of occupational safety and protection. Supported by guidelines, training and regular medical check-ups, Formycon pursues the goal of minimizing the likelihood of accidents at work and at the same time ensuring the safety and well-being of our entire workforce.
Formycon attaches great importance to the health of its employees and offers, in addition to the mandatory examinations, flu vaccinations and consultations on ergonomic working as well as first aid courses, all provided by the company physician. Together with an external service provider, we regularly conduct anonymous surveys on psychological risk to identify any potentials for improvement. We also offer our employees access to an online mental health platform that provides professional psychological counseling online. In addition, measures that are intended to further improve the processes implemented to ensure health protection are identified and implemented on a continuous basis.
Training and skills development
The #TeamFormycon is first-class, committed and operates at the cutting edge of medical research. A positive and productive atmosphere is essential for us, and we attach great importance to learning from each other and developing professionally.
To achieve this, Formycon offers individual opportunities for further education and training at a professional level. In addition to a Scientific and Clinical Career Path for Formycon scientific staff, a Managerial Career Path for employees of the Regulatory Affairs, Quality Management and Project Management departments has been implemented to promote personal career planning within the company. Formycon supports participation in seminars, congresses and lectures both in-house and with external partners. There are not only seminars on technical skills available, but our employees can also choose to attend training in areas such as languages, personal coaching, resilience and leadership. We also want to set an example for the next generation and plan to expand our trainee program in several specialist areas in addition to our existing apprenticeships in the field of IT.
Supply chain
Responsibility in the value chain
In addition to taking responsibility for our own employees, Formycon is committed to respecting human rights throughout the value chain. We want to ensure that all involved in the value chain are treated with dignity and respect, and thus contributing to sustainable development and social justice. As a biosimilar developer, we do not have own manufacturing facilities nor do we source materials in large quantities. Therefore, we aim to work with strategic business partners to uphold human rights along the value chain. To this end, we have created our Supplier Code of Conduct, which explains our values to our partners and makes it clear that we expect them to act in accordance with the Code of Conduct. It is based on the 10 principles of the United Nations (UN) Global Compact, the UN Guiding Principles on Business and Human Rights, the OECD Guidelines for Multinational Enterprises and the conventions of the International Labour Organization (ILO). We will also increasingly include ESG criteria in the selection of our suppliers and business partners. In doing so, we seek dialogue and engagement with our partners to increase the transparency of the value chain and to ensure that human rights are respected.
Patients
We are driven by the aim to improve access to modern and effective therapies for patients who have so far been underserved. Our contribution is to develop biosimilars and market them at a lower cost than the original substances. In this way, Formycon not only helps patients worldwide, but also contributes to the sustainable financial relief of healthcare systems.
The safety and quality of our medicines for our patients is a top priority. The development of biosimilars for highly regulated markets requires high standards of safety, quality and efficacy of the drugs. The quality assurance requirements for the production processes related to medicinal products and active ingredients are defined by the European Commission in the Principles and Guidelines of Good Manufacturing Practice (GMP) for medicinal products for human use. Formycon’s laboratories are managed under these guidelines and recurringly inspected and audited by regulatory bodies such as the U.S. Food and Drug Administration (FDA).
„Taking responsibility together – not just for our projects but on a larger scale with regard to social and environmental issues – is an important step towards a more sustainable future. I’m glad that such high importance is placed on sustainability themes at #TeamFormycon.“
Qiyun Tang
Associate Manager Regulatory Affairs
The conduct of clinical trials concerning medicinal products for human use is strictly regulated by the Good Clinical Practice (GCP) regulation. The GCP Regulation is valid worldwide and serves to protect patients and the integrity and accuracy of the data and findings generated during such studies. We monitor the compliance with all relevant regulations and standards very closely, not only within our own operations, but also at the sites of our business partners.
We ensure the high quality and safety of our products for patients now and in the future and are working to make them available globally. In addition, we conduct research on and develop more patient-friendly methods to administer our products.
Animal welfare
At Formycon, all our products must be safe, effective, and efficient and developed in full compliance with legal requirements. For the development of biosimilars, it is usually not legally required to test the drug substances on animals. However, in rare cases, we are mandated by law to conduct testing of our products on animals before clinical trials can take place on humans.
Formycon is aware that animal experiments raise a special responsibility. For this reason, we not only comply with all laws and regulations regarding animal testing, but we also enact strict internal rules to ensure that they are treated respectfully and ethically. These rules are based on the 3R principle – to completely avoid animal experiments (Replace), and to minimise the number of animals (Reduce) and their suffering (Refine) in experiments as much as possible.
A careful evaluation takes place before each study, with specific emphasize on the purpose of the study, the effects on the animals and the reasons why no results can be obtained otherwise. The study will only take place if animal experiments are prescribed by mandatory regulation or results cannot be obtained by an alternative method. In addition, all employees who participate must be properly trained and qualified to conduct animal testing. Of course, this also applies to our business partners and their employees.
Strategy
Strategy and areas of action
Environment. Social. Governance.
The sustainable orientation of our business processes contributes to reducing our ecological footprint, promoting social justice within the company and along the value chain and ensuring responsible corporate governance. In this sense, we see sustainability as an integral part of our self-image as a highly specialized biosimilar developer.
Environment
- Mitigation of climate change
- Adaptation to climate change
- Circular economy
- Biodiversity and ecosystems
- Water
Social
- Equal treatment and equal opportunities
- Training and skills development
- Working conditions
- Occupational health and safety
- Employees in the value chain
- Access to products and high-quality information
- Product safety and quality
- Responsible marketing
Governance
included:
- Corporate culture
- Compliance and business integrity
- Corruption and bribery
- Protection of whistleblowers
- Lobbying
- Management of relationships with suppliers
Strategy and areas of action
To better integrate sustainability into our business activities, we developed our first sustainability strategy in 2023 – a conscious commitment to society and the environment. The focus on sustainability within our business processes helps reduce our ecological footprint, promotes social justice within the company and along the value chain, and ensures a responsible corporate governance. In this sense, we see sustainability as an integral part of all our business activities as a highly specialized biosimilar developer.
Within our sustainability strategy, we have identified areas of action that are of high importance to our business and our entire value chain. Our sustainability strategy addresses the three areas of Environmental, Social and Governance topics (ESG) and is aligned with the European Corporate Sustainability Reporting Directive (CSRD)1. We have defined specific measures in all fields of action to achieve the goals we have set. Thus, the sustainability strategy addresses our material issues and provides a framework for our actions in the coming years.
We are committed to transparency and continuous improvement in all areas of our sustainability efforts. The annual updating of our materiality analysis2 and the review of our goals and measures will help us to continuously improve our sustainability performance while ensuring our long-term economic success.
1 CSRD
The CSRD reporting form on sustainability aspects is based on twelve binding standards, the set of European Sustainability Reporting Standards (ESRS). The aim of the CSRD is for companies to publish comparable, detailed and reliable sustainability information.
2 Materiality analysis
We use the materiality analysis to evaluate sustainability aspects from two perspectives. Firstly, we analyze the impact of our business activities on the environment and society, which is referred to as the impact perspective. Secondly, from a financial perspective, we assess which sustainability issues have or could have a material impact on our financial position and our company’s success. An issue is considered material if it has either an actual or potential positive or negative impact of our business activities on the environment and people, or if it creates risks or opportunities for our company’s success.
Our areas of action in detail
Governance (ESG)
Governance
Corporate culture & Compliance
Taking responsibility is an important step towards a sustainable future. That is why our business conduct is based on integrity and honesty.
Corporate culture
Our culture is based on team spirit and cooperation, with our employees contributing their different experiences, perspectives and ideas to the company. This type of diversity and engagement is a great enrichment and, together with the exceptional expertise of our employees and an agile corporate culture orientated towards sustainable growth, what makes Formycon successful.
Formycon has succeeded in recruiting and integrating outstanding talents into the organization. In addition, with our newly developed employer branding concept, we not only want to be perceived by applicants as an attractive employer, but we also firmly anchor our basic principles of corporate and leadership culture throughout the organization.
Coffee with your CXO
According to Formycon’s understanding of good leadership, personnel management, employee engagement, sustainable management and corporate success are directly related. That is why Formycon attaches great importance to a culture of mutual trust, which is intended to encourage an open and free exchange of opinions across all hierarchical levels. To encourage such an exchange, we offer regular “Company Meetings” and “Coffee with your CXO” where all employees can participate and ask questions directly to the management. Formycon sees a leadership culture characterized by strong values, empowerment and accountability as essential to achieving the company goals. For this reason, our HR department offers managers training courses on personnel management at regular intervals and advises them in the performance of their management tasks.
„From my very first day at Formycon, I was – and today still am – part of a strong team that supports each other and where everyone interacts at an equal level, regardless of whether I am dealing with my colleagues in IT or with the Management Board.“
Patrick Stevens
Trainee IT specialist for systems integration
Compliance
Formycon’s corporate success depends, among other things, on the expertise of highly qualified employees whose behavior is characterized by a sense of responsibility and ethical principles. Compliance with the Formycon Code of Conduct is one of the cornerstones for responsible and lawful action. Management, employees and all those who act on behalf of Formycon are obliged to comply with our Code of Conduct, regardless of where and in which area of activity they work. Formycon does not tolerate any violations of the Code of Conduct or applicable law, and will investigate any incident of non-compliance. In addition to these measures, Formycon has also implemented a whistleblowing tool enabling the anonymous reporting of potential violations of the Code of Conduct or applicable law. The tool thus helps to create an environment in which ethical behaviour is promoted and violations are effectively uncovered, tracked and dealt with appropriately.
Highly regulated environment
As a developer of biosimilars, Formycon and its business partners operate in a highly regulated environment and are subject to regular audits by official authorities. The main reason for the strict regulation is primarily patient safety as well as the complexity related to the development of biopharmaceutical products. However, ethical, honest and transparent behavior is just as important for us in other areas such as research and development and marketing.
For these reasons, Formycon reviews and monitors all relevant processes, procedures and decisions by internal and/or external persons with regards to compliance. Thereby, we ensure compliance with applicable legal and regulatory requirements, our Code of Conduct and other policies as well as related guidelines and SOPs (Standard Operating Procedures). The relevant requirements are reviewed regularly and adjusted if necessary. Our internal training system as well as random and event-related individual case-by-case reviews ensure that the respective requirements are observed and adhered to.
Animal welfare
At Formycon, all our products must be safe, effective, and efficient and developed in full compliance with legal requirements. For the development of biosimilars, it is usually not legally required to test the drug substances on animals. However, in rare cases, we are mandated by law to conduct testing of our products on animals before clinical trials can take place on humans.
Formycon is aware that animal experiments raise a special responsibility. For this reason, we not only comply with all laws and regulations regarding animal testing, but we also enact strict internal rules to ensure that they are treated respectfully and ethically. These rules are based on the 3R principle – to completely avoid animal experiments (Replace), and to minimise the number of animals (Reduce) and their suffering (Refine) in experiments as much as possible.
A careful evaluation takes place before each study, with specific emphasize on the purpose of the study, the effects on the animals and the reasons why no results can be obtained otherwise. The study will only take place if animal experiments are prescribed by mandatory regulation or results cannot be obtained by an alternative method. In addition, all employees who participate must be properly trained and qualified to conduct animal testing. Of course, this also applies to our business partners and their employees.
Environment
Environment
Focus on climate and nature
The key objectives for protecting our environment are to consistently and permanently reduce greenhouse gas emissions in our operations and to increase resource-conserving and material-efficient processes.
Environment
For Formycon, the topic of climate change mitigation and energy is particularly important. This is due to the high energy consumption and the greenhouse gas emissions generated during the development, production and distribution of our biosimilars along the value chain. It is therefore particularly important to consistently and permanently reduce greenhouse gas (GHG) emissions in our value chain and implement resource-saving and material-efficient processes. For this purpose, we calculated our own GHG emissions in 2023 and will expand the GHG balance to include the upstream and downstream value chain in 2025.
Based on the emissions analysis, we will develop a climate strategy to continue our path to reducing our GHG footprint. In line with this, we are implementing an Energy management system certified according to ISO 50001, and will expand the certification to include the environmental management system ISO 14001 by 2026. We also aim to work together with our strategic business partners on ESG topics along the value chain and are in the process of including sustainability criteria for both existing and new partnerships. An important step in setting binding values for cooperation with our partners was the development of our Supplier Code of Conduct in 2024. This complements our Supplier Code of Conduct, which defines our values and constitutes the framework for working with our partners.
Conserving resources and ecological diversity
In addition to curbing climate change, the preservation of ecological diversity has a high priority. To achieve this, the responsible use of water as a resource and the implementation of circular business processes where possible, are essential in our business model. In recent years, we have for instance implemented measures at our own site to save water and to improve waste handling, e.g. by separating waste. However, the greatest negative effects are primarily to be found in the downstream value chain – in the manufacturing and product end phase. That is why we want to engage more with our business partners and work on solutions together.
Responsibility
Responsibility
Improving access to important
medicines
Our mission is to become a driving force in the field of biosimilars. That way, we can make a sustainable contribution to global healthcare: We are committed to improving access to cutting-edge and effective therapies through affordable medicines worldwide. With our biosimilars, we are not only helping many previously underserved patients, but are also helping to ease the financial burden on healthcare systems.
Our Mission
The number of noncommunicable diseases (NCDs) is increasing rapidly worldwide and NCDs are currently responsible for almost 75% of all deaths worldwide. Thus, the need for innovative therapies for chronic diseases or cancer is growing rapidly1.
Over the years, the knowledge about the human immune system has grown significantly and in the last 40 years, the development of biological therapies (biologics) has gained momentum.
Biologicals have significantly improved the treatment of many serious diseases and now account for more than a third of the pharmaceutical market in Germany2. However, biologics are usually very expensive. Due to the high cost of treatment, and even in countries such as Germany, patients are often only eligible for biopharmaceutical therapy after long waiting times and when all other options have been exhausted.
Formycon is pursuing a clear goal
Formycon’s contribution is to improve access to essential medicines. To this end, we have focused on and are specialists in the development of biosimilars. Biosimilars are successor products of biopharmaceutical drugs whose legal protection periods have expired. When biosimilars enter the market, they create a competitive dynamic that increases cost efficiency in the market and improves access to therapy. For the cost bearers within the healthcare sector, such as health insurers, the cost savings arising from biosimilars mean that more patients can be treated with biopharmaceutical substances than previously.
Thus, Formycon is pursuing a clear goal: With our business model, we want to provide as many people as possible with cost-efficient and high-quality biopharmaceutical follow-up drugs to combat serious diseases and relieve the burden on healthcare systems worldwide.
„The clinical trials show for the first time what improvements in clinical symptoms we can achieve for patients with our biosimilars – and that our work is important.“
Andrey Trukhmanov
Clinical Development Manager
Responsible management
However, our contribution to society goes beyond the development and delivery of biosimilars; additionally, our main responsibility is to minimize any negative impact arising from our business activities on environment and society and to meet the expectations and needs of key stakeholders. Therefore, Formycon bases its business decisions on the principles of corporate responsibility and sustainable management.
1 Increasing adoption of quality-assured biosimilars to address access challenges in low- and middle-income countries, Generics and Biosimilars Initiative Journal, May 2024, https://gabi-journal.net/increasing-adoption-of-quality-assured-biosimilars-to-address-access-challenges-in-low-and-middle-income-countries.html
2 Biopharmaceuticals account for more than a third of the pharmaceutical market, aerzteblatt.de, January 2024, https://www.aerzteblatt.de/nachrichten/148389/Biopharmazeutika-machen-mehr-als-ein-Drittel-des-Arzneimittelmarktes-aus
