Biocon And Mylan's Fulphila And Insulin Plans On Track
FDA Expected To Inspect Malaysia Insulins Facility In February
Biocon and Mylan press ahead with plans to broaden patient access in the US to biosimilar pegfilgrastim and are enthused with the initial uptake for their trastuzumab biosimilar ahead of more upcoming competition. A mid-2020 US launch for partnered insulin glargine is also on course.
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Biocon is actively expanding its biosimilars manufacturing capacity with an aim to further penetrate EU markets after receiving a GMP approval for a key manufacturing site. The company has ramped up production for trastuzumab and pegfilgrastim, while awaiting approval for bevacizumab.
Mylan and Biocon have introduced the second biosimilar pegfilgrastim rival to Neulasta in Canada with the launch of their Fulphila version.
Sanofi’s Lantus stands alone as the only insulin product still listed in the ‘Orange Book’ post-transition because it is referenced in Mylan/Biocon’s pending 505(b)(2) application for insulin glargine; the FDA said it stands ready to review biosimilar and interchangeable applications that reference the newly ‘deemed’ biologic products.