Biocon-Mylan win US nod for another biosimilar drug

MUMBAI: Biocon-Mylan won US approval for their second biosimilar drug on Tuesday, a little over six months after their first such offering was accepted.
The US Food and Drug Administration approved pegfilgrastim, a drug used to increase the white blood count of cancer patients, Biocon and Mylan said in a statement on Tuesday. The drug, branded Fulphila, is a follow-on of the medicine developed by Amgen and has a market size of $4 billion.

Biosimilars are emerging as the new class of affordable drugs that are replacing those with expired patents in the US. Unlike generic medicines, the complex molecular structure of biosimilar drugs means pharmaceutical companies have to invest in additional research to prove that the efficacy of their versions is similar to the original.

Biosimilars are identical copies of highly complex biologic drugs, which are made through biotechnology, derived from natural sources or produced synthetically.

“It takes time for people to understand and embrace biosimilars. I think there is a huge momentum, better than what we anticipated and expected,” Mylan CEO Rajiv Malik said in a telephonic interview to ET.

Mylan has tied up with Bengaluru based Biocon and the partnership has seen success with two biosimilar drugs, the first one being Ogivri, a version of trastuzumab, used to treat breast cancer. The FDA approved Ogivri in December.

Mylan has the rights to market and sell the drug in the US, Canada and Europe. Malik said the company expects to play on the affordability factor of the drug. Innovator drugs can cost much more than traditional prescription drugs and high cost can prohibit access, Malik said.

The company said that a survey by the American Society for Clinical Oncology showed that more than half (56%) of the respondents said they were very or somewhat concerned they could afford treatment. This was when biologics accounted for 70% of drug spending growth between 2010 and 2015.

“Our goal is to provide an affordable access. You will definitely see a price reduction to the innovator, but I cannot comment on them,” Malik added.

Following the announcement of the approval, Biocon shares jumped by more than 6 per cent. They subsequently fell more than 7 per cent to Rs 607.70 at the close on the BSE.