Biocon, which remains in news on developments regarding biosimilars, also received an EIR for its small molecules’ active pharmaceutical ingredients (API) plant on Friday. EIR is an establishment inspection report, which is given by US FDA upon closure of its inspection. The clearance of Biocon’s plant by the FDA, while reducing regulatory overhang also means that growth in small molecules business will sustain.
However, the Street interest is more on the progress and success in Biosimilars. While the company along with its partner won a patent ligation asserted by Sanofi for insulin Glargine device patent in the US last week, it also filed for another oncology biosimilar in the US markets.
The US District Court of New Jersey found that the device patent claims asserted by Sanofi for Solostar against Mylan/Biocon’s insulin GLARGINE, do not infringe Sanofi’s patents and are invalid for lack of written description. This would clear the way for commercialisation of insulin Glargine in the US.
While the patent win has raised expectations of an early launch of Glargine in the US, analysts remain watchful on developments pertaining to three observations that Biocon had received for its Malaysia plant. While Biocon is confident of addressing the procedural issues, Mylan believes that the inspection will not hamper the commercialisation plans for Glargine.
Meanwhile, Mylan and Biocon also filed for the biosimilar of another oncology drug AVASTIN (Bevacizumab) with the US FDA. The application review is to be completed by end of 2020. Analysts feel that this could be the third oncology biosimilar of Biocon in the US. Looking at the global market size for the drug at $7 billion, the opportunity remains big for Biocon.
Biocon had recently commercialised Ogivri, a biosimilar for oncology drug Trastuzumab, in the US. The company already continues benefitting from earlier launch of oncology biosimilars (Pegfilgrastim), which is ramping up in the US. The company’s new manufacturing facility in Bengaluru having received additional approval for manufacturing of Pegfilgrastim, will help Biocon address the growing market opportunities in the US and other global markets.
Not surprisingly, analysts remain positive on forward prospects anticipating strong earnings growth. Analysts at PhillipCapital India expect 32 per cent annual growth in earnings during FY19-22, as they expect Biocon to benefit from significant operating leverage and improved biologic sales by FY22 with the visible cumulative benefit of expanded Pegfilgrastim, Trastuzumab and Glargine. Biocon, too, plans to cross a revenue milestone of $1 billion by FY22, which should keep street sentiments firm.