Mylan and Biocon, which had expected to be first to market with a Herceptin biosimilar in Europe, have hit a stumbling block that could delay their bid and give Roche some breathing room before copies take a bite out of its $2 billion in sales there.
Biocon said (PDF) in a filing Sunday that the European Medicines Agency found issues with its product plant in Banglore and has told them a follow-up inspection will be required to insure Biocon implemented changes before the EMA will give it a thumbs up.
The Indian drugmaker said the EMA had reviewed its “corrective action” plan and that work was progressing following a March review by French inspectors. Two API plants that will provide ingredients were approved.
“Biocon, with its partner Mylan, will work with the French and European regulatory authorities with regard to the follow-up inspection of the drug product facility and the Marketing Authorization Applications with the goal of an early reinspection,” the company said in its statement.
Roche's EU patents on Herceptin expired in 2014, but it remains the Swiss group's third-biggest drug with sales of CHF 6.8 billion ($7 billion) last year, with about $2 billion that coming from the European market. Last year, Roche's head of pharma, Dan O'Day, said he did not expect biosimilars of the cancer drug to reach western markets until late 2017.
Europe is seen as a particularly productive market for biosimilars because it began using them several years ago and Europe’s national health systems, looking to cut costs, have been receptive to using them over the originals.
When Mylan and Biocon announced in August 2016 that their applications for the biosimilar had been accepted by the EMA, they said they believed that put them first in line for an approval. The duo already had approval of their product in India.
Samsung Bioepis, a joint venture between South Korea’s Samsung BioLogics and Biogen, was only weeks behind in making its application to the EMA and Celltrion and Pfizer's Hospira unit are also said to be preparing to file for approval of their own versions of the big-selling brand. Allergan and Amgen have a Herceptin biosim in late-stage testing.
In addition to its Herceptin biosimilar, the March inspection was also for Mylan's and Biocon’s biosimilar of Amgen’s Neulasta and the pen assembly for some of the insulin products Biocon intends to launch in Europe.
Biocon didn’t indicate in its announcement what specific concerns were raised by the French inspectors, but a copy (PDF) of the report posted by Pharmacompass showed that during the March reviews, inspectors noted nearly three dozen deficiencies, 11 of them major, ranging from management of out of spec results to cross contamination risks.