INSUBCONTINENT EXCLUSIVE:
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
understand and embrace biosimilars
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
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.
