Shares of Biocon Ltd. dropped the most in nearly a year as Amgen Inc and Allergan Plc launched the first biosimilars of breast-cancer drug trastuzumab in the U.S., denying the Indian company exclusivity benefit.
Trastuzumab has a market size of $3 billion in the U.S., according to a note by Edelweiss Securities. Bloomberg reported that Kanjinti, a biosimilar for Roche's Herceptin (trastuzumab), is now available in the U.S. after Amgen and Allergan won approval from the Food and Drug Administration.
The understanding was that Biocon would be the first to commercialise trastuzumab and enjoy six to nine months of exclusive sales, Deepak Malik, pharma analyst at Edelweiss Securities, said in an emailed response. With the launch by rivals, this assumption gets nullified and will lead to a cut in the street's earnings estimates for 2019-20 and 2020-21. Malik said Biocon was expected to launch the biosimilar in the second half of 2019.
Biocon's stock plunged as much as 9.52 percent, the most since June 5 last year, in Mumbai compared to a 1.65 percent decline in Nifty Pharma Index as of 1:55 p.m. The closed 8.65 percent lower on Friday.
A company spokesperson declined to comment on BloombergQuint's queries over the phone.
The U.S. FDA has approved three other trastuzumab biosimilars by Pfizer, Teva-Celltrion and Merck-Samsung, Malik said. If they launch before Biocon, the brokerage sees further risks to Boicon's earnings estimates.
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