Biosimilars are the future


Biosimilars: New class of highly-effective drugs at affordable prices

What are Biosimilars?
Biosimilars are approved biopharmaceutical products that are similar to a biological reference product in terms of quality, safety and efficacy (bio-similar). They are approved in highly regulated markets such as the EU, US, Canada, Japan and Australia via stringent regulatory pathways following loss of exclusivity of their originator reference products.

Biosimilars represent a rapidly growing new field of pharmaceutical biotechnology, analytical science, and clinical research. Their development requires a fundamentally different approach to that used for originator biopharmaceuticals, and analytical design becomes particularly important. Biosimilars are manufactured using state-of-the-art manufacturing techniques with high quality standards.

What are Biopharmaceuticals?
Biopharmaceuticals or biologics are highly-effective protein drugs produced biotechnologically in living cells. With the advent of recombinant DNA technology in the late 1970s, biologics emerged as a new source of medicines. In the 1990s, the first monoclonal antibodies, such as rituximab, infliximab, and trastuzumab, became available. Since then, the number of approved biologics has expanded greatly. Biopharmaceuticals have revolutionized the treatment of serious disease such as diabetes, multiple sclerosis, cancer, and more recently, also arthritis, skin and eye diseases.

Development and manufacturing of Biosimilars
Because of the seize, the structural complexity, and the living cell systems they are derived from, the development and production of biosimilars demand a great deal of time, effort and expertise. The reverse engineering of these drugs is made even more difficult because of the natural variations which occur in these biological molecules.

The essential principle in the development of any biosimilar drug is similarity with the established reference drug. To achieve this threshold, the producer of the biosimilar must ensure that the drug quality, safety and efficacy are comparable to the biologic reference product.

The time it takes to complete the development of a biosimilar is, on average, six to seven years. Their development involves a series of stages which are both essential and complex.

Because of the great challenges involved in developing and producing biosimilars, there are only a very limited number of companies in the world with the know-how and capabilities to develop and produce these new-generation drugs, particularly if it comes to meet the strict regulatory standards of the highly regulated markets.

Formycon is a leader among these companies, specifically concentrating upon the “third wave” of biosimilars, meaning new drugs to compete with established biopharmaceuticals for which patent protection will begin expiring from the year 2020 onwards.

Regulatory approval of Biosimilars
While the European Union began to lay out the regulatory approval process for biosimilars already in 2004/2005, the governing framework the United States has only been in place since late 2010. The first biosimilar has been approved in in the EU in 2006, whereas it took nine more years until the US approved the first biosimilar in 2015. Biosimilar drugs require a far greater investment of time and effort to gain regulatory approval than conventional generic drugs. To attain regulatory approval, the producer of the biosimilar must demonstrate similar quality, safety and efficacy, of the biosimilar and the original biopharmaceutical. This is proven by intensive analytical testing and clinical studies in addition to state-of-the-art manufacturing processes.

The market for Biosimilars
While biopharmaceuticals are remarkably effective at treating serious diseases, they are at the same time often very costly, posing a financial burden for the healthcare systems even of wealthy developed countries. Because biosimilars provide competition and are typically 20- to 30 percent less expensive than the original drugs, they help to reduce the costs to healthcare providers and thus to make these drugs available to more patients.

Biosimilars are currently the most rapidly growing segment of the world’s pharmaceutical market. Analysts estimate that, by the year 2020, biopharmaceutical drugs with combined annual revenue of some USD 100 billion will lose their patent protection. The global market for biosimilar drugs, currently estimated at approx. USD 3.0 billion, could thus grow tenfold by the year 2025, in the view of industry experts.

More Information in the Handbuch Biosimilars of the Arbeitsgemeinschaft Pro Biosimilars (in German language only).