- Indian drugmaker Biocon Ltd. said it will withdraw its application for EU approval of its biosimilar version of Roche's blockbuster cancer drug Herceptin, after the European Medicines Agency informed the company it would need to re-inspect a drug product facility.
- Biocon, which is partnered with Mylan N.V. on biosimilar development, expects to complete the needed corrective and preventative actions by the end of the third quarter, and will subsequently seek re-inspection and resubmit the copycat biologic.
- Also affected is the company's application for EU approval of a biosimilar of Amgen Inc's Neulasta (pegfilgrastim). The Neulasta biosimilar was accepted for review in July 2016, while the Herceptin biosimilar first hit the EMA's desk a month later.
The biosimilar threat to Roche AG's trio of top-selling biologics — Herceptin (trastuzumab), Rituxan (rituximab) and Avastin (bevacizumab) — has grown, but the Swiss pharma remains unfazed, at least for now.
In the EU, several biosimilars of Rituxan are already on the market, and Herceptin looks like the next in line to be challenged. But Biocon's withdrawal will mean at least one potential rival will be delayed for some time.
Elsewhere, Amgen and Allergan plc, as well as Korean drugmaker Celltrion, Inc., have filed for approval of Herceptin biosimilars in the U.S.
In the first half of 2017, Herceptin was Roche's second highest-selling pharmaceutical, with sales up 6% in the U.S. and 3% in Europe.
Roche is counting on new, recently launched drugs to drive overall revenue growth and help offset any sales erosion due to biosimilars. For Herceptin specifically, the Swiss company is developing a subcutaneous formulation of the drug to help boost convenience. Roche also hopes its APHINITY trial will push physicians to prescribe Herceptin together with Perjeta (pertuzumab) for treatment of HER2-positive early breast cancer.
Mylan and Biocon would have faced legal challenges in the U.S. for their Herceptin biosimilar, but a settlement with Roche now means that Mylan has a license to market the drug in all countries except Japan, Brazil and Mexico. An advisory panel to the Food and Drug Administration has unanimously recommended approval for the biosimilar, setting up an approval decision date of September 3.
Mylan has also separately run into manufacturing issues, recently receiving a warning letter from the FDA for its production facility in India due to data integrity and quality control issues.