Drug majors Mylan and Biocon on Friday said the US health regulator’s Oncologic Drugs Advisory Committee (ODAC) has recommended approval for their proposed biosimilar trastuzumab, indicated for breast cancer treatment. USFDA annoucement of the biosimilar expected in the month of September.
In a regulatory filing, Biocon said the committee voted 16-0 in support of eligible indications of the reference product.
- Mylan has entered into a settlement with Roche over Herceptin, which clears the way for a launch globally. That means it can launch in the US, without any issues, once it gets the US FDA’s final approval.
- Biocon’s ability to get plant-level clearances and Mylan/Biocon’s ability to pass the remaining regulatory process will be crucial.
- Mylan will launch the product in most developed markets, including the US and Europe, while Biocon will launch it elsewhere.
- Important will be how long this will be sole biosimilar and how much market they can capture will be the point to look for. This only can be understood only after a three to four month of the full market launch.
- Pricing will be a key factor. Pricing strategy should be interesting to watch. Whether it will be 20-30% lesser or more from the original product.
- An actual US/Europe market launch is the next milestone.
And Another crucial point will be getting accepted by the healthcare professionals in launched market.
Biocon’s Biosimilar Portfolio: