Mylan and Biocon Herceptin biosimilar delayed by FDA for 3 months

Mylan and Biocon, which have had trouble getting to the regulatory finish line in Europe with their biosimilar of Roche’s blockbuster Herceptin because of manufacturing concerns, now face a three-month delay in the U.S.

Biocon insists, however, the FDA delay has nothing to do with issues that were also raised by the FDA about the sterile plant where the drug is produced.

In a comment to The Economic Times, the company said: "The extension of the target action date is linked to the review of the clarificatory information sought as part of the application process. This information is not related to any GMP audit observations at our manufacturing facilities."

The drug was slated to be considered in early September, but Biocon said in a filing (PDF) that the FDA told Mylan it will extend the target action date for their Trastuzumab application to Dec. 3 in order to review some "clarificatory information." Biocon said in the filing that the extension would not affect its timetable for getting the product to market in the U.S.

RELATED: FDA slams Biocon sterile plant where Herceptin biosimilar is to be produced

An FDA advisory committee in July voted unanimously to recommend Mylan’s proposed Herceptin biosim to treat HER2-positive breast cancer, both for patients after surgery and for metastatic disease. A few weeks later, it was learned that the FDA had written up (PDF) in a Form 483 the Biocon sterile plant in India where the drug is being produced.

The seven-page, 10-observation citation stemmed from an inspection last spring in which reviewers noted problems across the entire range of processes, including in aseptic processing and filling, environmental monitoring, data recording, cleaning procedures and even in its processes for buying sterile gloves for employees.

RELATED: Biocon pulls EU Herceptin biosim app but expects to return to the race next quarter

Then Biocon in August withdrew the partners’ application for the biosimilar in Europe after the European Medicines Agency also found issues with the plant in Bangalore. The EMA told Biocon that a follow-up inspection would be in order before the Herceptin knockoff, and a biosimilar of Amgen’s chemo companion drug Neulasta, will be considered for approval.

Even a small delay is a big deal for Roche. Herceptin is the Swiss group's third-biggest drug with sales of about $7 billion last year, about $2 billion of that coming from the European market.