Mumbai: Mylan NV and Bengaluru-based Biocon Ltd said on Friday that the US Food and Drug Administration’s (FDA) oncology drugs advisory committee had recommended approval of their biosimilar trastuzumab, indicated for treatment of breast cancer.
Based on data submitted by Mylan-Biocon for their biosimilar trastuzumab, the committee determined that no clinically meaningful differences existed between the biosimilar product and Roche Holding AG’s innovation drug Herceptin in terms of safety, purity and potency and concluded that the evidence supported a recommendation for FDA approval.
Biosimilars are a type of biological product that are shown to have no clinically meaningful differences from an existing, licenced product.
“The committee voted 16-0 in support of eligible indications of the reference product, Herceptin, which include HER2-positive breast cancer in the metastatic and adjuvant settings," the companies said in a joint statement.
This development sent shares of Biocon surging to a record high of Rs404 in intraday trading. So far in 2017, the stock has risen 25%. At 11:35am, shares of the company were up 7.9% at Rs395.75 on the BSE, while the benchmark Sensex was down 0.2% at 31,970.03 points.
FDA uses advisory committees and panels to obtain independent expert advice on a variety of matters, including product approvals.
“This is a big positive for Biocon. Here onwards only obstacle to approval is resolution of observations at Bangalore plant which company is confident to resolve. The company has already settled with innovator for launch in mid-2019. Key thing to watch is how many more players come up before mid 2019. Five players are in the queue," Edelweiss Securities Ltd said in a note.
The US drug regulator had made eight observations relating to deviations from good manufacturing practices at Biocon’s Bengaluru unit after a site inspection between 27 March and 7 April this year.
The company said in May that it had responded to queries regarding the violation of norms at the plant within stipulated timelines.
“We now look forward to engaging with the FDA to seek final approval in order to expand access to a high-quality, affordable option for treating HER2-positive breast cancers," Arun Chandavarkar, chief executive officer and joint managing director of Biocon, said in the statement on Friday.
Mylan and Biocon’s proposed biosimilar trastuzumab is also under review by regulatory authorities in Australia, Canada, Europe and several emerging markets.
Earlier this week, Biocon had said the French National Agency for Medicines and Health Products Safety, on behalf of the European Medicines Agency (EMA), had conducted a pre-approval inspection of the drug product and drug substance manufacturing units relating to applications filed with European regulator for biosimilars trastuzumab and pegfilgrastim, which is used to stimulate the growth of white blood cells in the bone marrow, which help fight infection, after chemotherapy is given.
While the regulator issued GMP (good manufacturing practices) compliance certificates for Biocon’s two drug substance manufacturing units, it made certain observations on the drug product site.
Until the drug product facility gets clearance, Biocon will not get marketing approval for its biosimilars in the European market.
Mylan and Biocon are exclusive partners on a broad portfolio of biosimilar and insulin products. The proposed biosimilar trastuzumab is one of the six biologic products co-developed by the companies.
Mylan has exclusive commercialization rights for biosimilar trastuzumab in the US, Canada, Japan, Australia, New Zealand and in the European Union and European Free Trade Association countries. Biocon has co-exclusive commercialization rights with Mylan for the product in the rest of the world.