Mylan and Biocon win FDA nod for Herceptin copy and move biosim forward in EU

Mylan and Biocon are among a host of biosim developers that are working to grab a piece of Roche’s global cancer fortunes.

Mylan and Biocon today became the first drugmakers to win an FDA approval of a biosimilar of Roche's blockbuster cancer drug Herceptin, a med that raked in $2.5 billion in U.S. sales last year. Its approval had been slowed by FDA and EU concerns over Biocon's manufacturing facilitiy. 

The FDA said it approved Ogivri as a biosimilar to Herceptin for the treatment of patients with breast or metastatic stomach cancer whose tumors overexpress the HER2 gene. 

The news came shortly after the two also announced that the European Medicines Agency (EMA) has accepted their resubmitted application for their Herceptin biosimilar, as well as for their copy of Amgen’s chemo drug, Neulasta. The agency accepted the new application after approving their plan to fix issues at the plant where the biosimilars are being made.


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Mylan and Biocon pulled their applications with the EMA in July after an inspection of a Biocon sterile plant in Bangalore, India, uncovered issues with aseptic filling and other processes. It is the same plant where FDA inspectors earlier noted problems.

RELATED: Biocon and Mylan Herceptin biosimilar stalled in EU over plant issues

The two were allowed to resubmit the applications to the EMA while they await a reinspection of the plant to confirm their corrective and prevent action plan is doing what is needed. Two weeks ago, they said that the FDA also had indicated that their intended improvements at the plant were acceptable.

“Having gone through initial reviews of the applications and after completing the CAPAs from the EMA audit, we are even more confident with the strength of our MAAs,” Mylan President Rajiv Malik said in a statement. “Additionally, the Voluntary Action Indicated (VAI) designation we received from FDA gives us further confidence in the readiness of the manufacturing site.”

RELATED: Mylan and Biocon Herceptin biosimilar delayed by FDA for 3 months

The FDA approval comes after a three-month delay. They had been slated for an action date on Sept. 3, but that was pushed off while the FDA considered additional information. An FDA advisory committee in July voted unanimously to recommend their proposed Herceptin biosim to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease.

Mylan and Biocon are among a host of biosim developers that are working to grab a piece of Roche’s global cancer fortunes. The EMA has already approved a Herceptin copy developed by Samsung and Biogen. In September, Amgen and Allergan won U.S. approval for Mvasi, an Avastin biosim approved in each of the branded drug’s indications. Amgen and Allergan’s approval represents the first cancer biosim nod in the U.S. and a threat to $3 billion in Roche sales in the states. The two are also advancing a Herceptin biosim in the U.S., as are a Teva-plus-Celltrion collaboration.

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