Novartis strikes biosimilar deal while Mylan biosimilar held up by manufacturing issue

Novartis’ biosimilars and generics arm Sandoz has struck a deal with Polpharma Biologics to market a proposed biosimilar of Biogen’s multiple sclerosis drug.

Tysabri’s (natalizumab) main US and European patents expired in 2015 but so far the drug is still a blockbuster, bringing in $475 million for Biogen in Q2 alone, with sales still growing slightly despite competition from newer drugs that can be taken as pills, or have fewer side-effects.

Under the agreement Poland’s Polpharma will still develop, manufacture and supply the proposed biosimilar, which is in phase III clinical development.

Sandoz will market and distribute it in all markets upon approval through an exclusive global license, but did not disclose further financial details.

This is the fifth potential biosimilar that Sandoz has in-licensed in nine months, as the company prepares for a likely split from Novartis while CEO Vas Narasimhan reshapes the company over the next few years.

Pierre Bourdage, ad interim Global Head of Biopharmaceuticals at Sandoz, said: “Patient access to advanced medicines is important for all people diagnosed with a chronic disease, but the challenges are very pronounced for MS patients.

“With this agreement, we hope to build on our MS experience with small molecules and complex generics, and ultimately provide patients with expanded access to a (disease-modifying therapy) that healthcare systems may otherwise not be able to provide.”

Mylan’s hopes of grabbing a slice of the big US market for insulin glargine – the active ingredient in Sanofi’s Lantus blockbuster – have been dealt a blow.

The FDA has issued a second complete response letter (CRL) rejecting the marketing application for the biosimilar after uncovering quality problems at Biocon – Mylan’s partner for the drug – in a pre-approval inspection of one of its manufacturing facilities in Malaysia.

Mylan, which is due to merge with Pfizer’s Upjohn unit next year, is trying to bring the second Lantus copycat to market in the US after Eli Lilly and Boehringer Ingelheim’s Basaglar, which was approved by the FDA in 2014 and launched under an agreement with Sanofi at the end of 2016.

Source: https://pharmaphorum.com