Biocon, Mylan plan appeals of Delhi court ruling on biosimilar

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Roche HQ

Bangalore-based Biocon plans to challenge a Delhi High Court ruling that its breast cancer therapy version of trastuzumab (Herceptin) cannot be labeled as a biosimilar. The case that may set a higher bar in India on these types of copycat biologics.

CANMAb from Biocon and Mylan's Hertraz were approved by India's drug regulator in 2013--but the court said they did not conform to India's Drugs and Cosmetics Act definition of biosimilars to the reference product. The two therapies compete with Roche's ($RHHBY) Herceptin in India, sold under the brand names Herclon and Biceltis.

The Economic Times said Biocon would move to appeal the ruling, which does not halt sales of the Biocon or Mylan versions. Mylan also told the newspaper it would appeal.

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At stake is the language on the packaging and any use of data from Roche's own work on trastuzumab in product inserts.

That potentially sets up a challenge on data exclusivity in India for biosimilar drugs that will be closely followed by domestic drugmakers concerned that the government wants to push tighter intellectual property standards in a backdoor manner.

A Roche spokesman in India said the court decision: "Sent a strong, positive signal that the development, manufacture and approval of biosimilars in India must be subject to rigorous clinical and regulatory standards."

A further hearing on the case is scheduled for May 10.

Earlier this week, Biocon reported that fourth quarter net profit rose 97% to INR 3.61 billion ($54.2 million) on net sales of INR9.7 billion, with the company adding that it plans to file biosimilars in India and abroad.

"Biocon's gross R&D expenses at INR1.52 billion ($22.8 million) this quarter were  the highest till date reflecting the advancement of our innovation led drug pipeline comprising novels, biosimilars and ANDAs. We expect to file a number of regulatory submissions in the U.S. and Europe for many of these programs," said Kiran Mazumdar-Shaw, chair and managing director of the company.

On the April 26 earnings call for the financial year ended March 31, Mazumdar-Shaw also noted the launch of trastuzumab in unspecified emerging markets.

In March, Biocon received approval in Japan for a biosimilar of Sanofi's ($SNY) blockbuster Lantus (insulin glargine), which it co-markets with partner Fujifilm.

It is also at work on filings abroad for trastuzumab, pegfilgrastim (Neulasta) and adalimumab (Humira).

- here's the Biocon earnings release
- and Live Mint on the trastuzumab case

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