Mylan and Biocon have approvals for their Herceptin biosimilar pending in the U.S. and Europe, but just today won a court ruling that said they may sell their version in India where it was first approved three years ago.
The Delhi High Court ruled that the partners have the right to sell their versions of the blockbuster breast cancer drug in India and refer to it as a biosimilar of Herceptin, the Statesman reports. The two developed the biosimilar together but are each launching their own brands there, CANMAB by Biocon and Hertraz by Mylan.
Roche has aggressively fought the introduction of the drug there since 2014, claiming that India’s drug regulator had approved the Mylan and Biocon drug before it had adopted guidelines for how biosimilars would be approved. The Swiss drugmaker claimed the two companies relied on Roche data, rather than their own, to develop their product and that there was no guarantee of biosimilarity and so shouldn’t be sold as one.
In a statement released by the court, Roche said it was disappointed by the decision.
While Mylan and Biocon have been wrestling with Roche in India, they have also marched steadily forward with their biosimilar in the EU and U.S. where the real money is to be made. They are hoping to be first to market with their copy of a product that generated $6.7 billion in revenues last year.
The European Medicines agency in August began its review of their drug, and in November they filed it with the FDA for treatment of certain HER2-positive breast and gastric cancers. But a gaggle of other drugmakers are not far behind.
South Korea’s Celltrion filed for approval in Europe shortly after Mylan, as did its compatriot Samsung Bioepis. Amgen and Allergan have posted phase 3 data on their contender while Pfizer's Hospira unit is also in the running.
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It is still unclear how the biosimilar market will play out in the U.S., where a number of biosimilars may hit the market this year. In Europe, with the introduction of copies of Remicade, pricing got quite aggressive in some countries, with discounts of up to 40% reportedly offered for the two versions introduced by Hospira and development partner Celltrion.
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Pfizer, which now owns Hospira, launched its version in the U.S. late last year. It has priced Inflectra at a 15% discount to Remicade and has a dedicated sales force behind the product.