• CIMERLI™ is the only biosimilar approved for all five Lucentis® indications
  • Commercially available in 0.3 mg and 0.5 mg dosages
  • U.S. commercial launch by Coherus BioSciences, Inc. expected in early October 2022

Munich, Amsterdam, Zug – Formycon AG (“Formycon”), Polpharma Biologics Group BV (“Polpharma Biologics”) and Bioeq AG (“Bioeq”) jointly announce, that the U.S. Food and Drug Administration (“FDA”) has approved CIMERLI™ (ranibizumab-eqrn), a biosimilar product interchangeable with Lucentis® (ranibizumab injection).

FYB201 was developed by Bioeq, a Joint Venture between Formycon and Polpharma Biologics. End of the year 2019, Coherus BioSciences, Inc. (“Coherus”) entered into a license agreement for the exclusive commercialization of FYB201 under the brand name CIMERLI™ in the United States of America (“U.S.”).

CIMERLI™ obtained approval from FDA for the treatment of Age-Related Neovascular (wet) Macular Degeneration (nAMD) and other serious retinal diseases such as Diabetic Macular Edema (DME), Diabetic Retinopathy (DR), Macular Edema following Retinal Vein Occlusion (RVO) and Myopic Choroidal Neovascularization (mCNV). CIMERLI™ is the first and only interchangeable biosimilar with an exclusivity of 12 month after market launch that is indicated for the treatment of all five Lucentis® indications and as such is a new medical option for patients with serious retinal diseases. [i]

FDA-approval and interchangeability designation are based on a totality of evidence including analytical, nonclinical, clinical and manufacturing data. Efficacy, safety, pharmacokinetics and immunogenicity of CIMERLI™ were found to be comparable to the reference drug Lucentis® in patients with Age-Related Neovascular (wet) Macular Degeneration (nAMD). Clinical readouts from the randomized, double-masked, parallel group, multicenter phase III study (COLUMBUS AMD) have been published in the peer-reviewed journal Ophthalmology. [ii]

CIMERLI™ belongs to the anti-VEGF therapy class of biologics that have been revolutionary in helping retinal patients in maintaining or regaining vision. It inhibits vascular endothelial growth factor (VEGF), which is responsible for the excessive formation of blood vessels in the retina. The U.S. market for ophthalmic drugs in anti-VEGF therapy is around $7 billion per year and, according to analysts, will continue to grow further. The commercial launch of CIMERLI™, in both 0.3mg and 0.5mg dosages, in the U.S. by Coherus, is planned for early October.

“We are very delighted about the full label approval as it will allow to offer this highly effective treatment option to an increasing number of patients with retinal diseases. At the same time, we would like to thank our partners Bioeq and Polpharma Biologics for the excellent joint development work and are pleased that Coherus acts as commercialization partner for the U.S.,” explained Dr. Stefan Glombitza, CEO of Formycon AG.

“As the impact of serious retinal diseases continues to rise in the U.S., it is critical that treatment options are both efficacious and affordable. Advanced biosimilars to Lucentis® can change patients’ lives, while also minimizing the financial impact of the cost of treatment on healthcare systems,” said Michael Soldan, CEO of Polpharma Biologics Group. “Polpharma Biologics is proud to have collaborated with Formycon and Bioeq on the development of ranibizumab biosimilar and we are excited about our contribution to this valuable treatment option that we expect to positively impact many patients lives.”

1) CIMERLI™ is a trademark of Coherus BioSciences, Inc.
2) Lucentis® is a registered trademark of Genentech Inc.

[i] U.S. Food and Drug Administration (FDA) website. Available from: https://www.fda.gov/
[ii] Holz FG, Oleksy P, Ricci F, et al. Efficacy and Safety of Biosimilar FYB201 Compared with Ranibizumab in Neovascular Age-Related Macular Degeneration. Ophthalmology. 2022; 129 (1): 54-63