Indian biotech Biocon has said its plan to launch two new biosimilars in Europe has been stymied by issues at its manufacturing facility.
In a statement, the company said it had been forced to withdraw its regulatory filings for biosimilar versions of Roche’s breast cancer drug Herceptin (trastuzumab) and Amgen’s long-acting white cell booster Neulasta (pegfilgrastim) at the request of the EMA.
Biocon revealed last month that a pre-approval inspection of its production unit in Bangalore by French regulatory ANSM revealed corrective and preventive action (CAPA) that would need to be addressed before a Good Manufacturing Practice (GMP) compliance certificate could be issued. At the time, it said that along with partner Mylan it would “work with the French and European
regulatory authorities with regard to the follow-up inspection of the drug product facility.”
Now, Biocon has revealed that the EMA has asked it to withdraw and re-submit its marketing applications for the two biosimilars as part of the regulator’s “procedural requirements”, adding that this will be “considered by the EMA’s Committee on Medical Products for Human use (CHMP)”. Shares in the company went in decline on the news.
The Indian company says it intends to complete the CAPA work by the end of this quarter and should be in a position to re-file thereafter. The net result of that however is that approval could be delayed by months as the EMA starts its review over. Analysts said it could be delayed by at least six months as a result.
Biocon and Mylan are among the front runners for securing approval for biosimilar Herceptin in Europe, but the delay could give rivals Samsung Bioepis – which has also filed with the EMA – and Celltrion and Pfizer’s Hospira unit which have a candidate in late-stage development time to catch up.
With regard to Neulasta the field is less competitive, as Novartis subsidiary Sandoz and Gedeon Richter both had applications for biosimilars withdrawn from the EMA in the last few months on concerns their bioavailability was not matching Amgen’s brand.
The partners also got a green light for their Herceptin biosimilar from an FDA advisory committee last month, but it remains to be seen whether the EU regulatory hiccup will have an impact on US approval, with the FDA due to deliver its verdict by September 3. Mylan has agreed a settlement deal with Roche to clear the way for a US launch if approved by the FDA.
Sales of Herceptin were around $7bn last year, while Amgen recorded almost $4bn in Neulasta revenues.