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Apotex has moved first on Allergan’s Combigan, introducing a US authorized generic as the clock ticks on the originator’s IP. Sandoz is among ANDA sponsors seemingly waiting for patent protection to lapse.
An induced-infringement attack on Hikma’s skinny-label generic version of Vascepa had been cited as evidence of the potential harm that would be caused by controversial rulings in separate litigation involving GSK and Teva. However, these fears may now appear overstated after the claim against Hikma was dismissed.
The first biosimilar approval stemming from Alvotech’s collaboration with JAMP Pharma in Canada has arrived, with the firms’ Simlandi (adalimumab) biosimilar version of AbbVie’s higher-strength Humira. Celltrion has also announced an approval from Health Canada.
In 2021, courts across the US and beyond continued to weigh key patent litigation fights, alongside the thorny issue of induced infringement via label carve outs and controversial charges for generic price fixing.
An attack on Hikma’s skinny-label generic version of Vascepa by originator Amarin, claiming induced infringement of patents protecting a cardiovascular indication, has been dismissed in the US.
Biosimilar sponsors need multiple reference product lots and expiration dates, and questions remain about whether they can obtain enough to fulfill all regulatory requirements under a CREATES Act mandate, Teva attorney says.
Viatris may be able to move earlier than anticipated with its Breyna proposed generic version of Symbicort, after the US Court of Appeals for the Federal Circuit found that a lower court had misinterpreted claims of Symbicort patents for which Viatris has stipulated to infringement.
The latest decision in US litigation with HEC Pharma over multiple sclerosis treatment Gilenya means that generics will be kept off the market for at least two years, according to originator Novartis.
After over two years of litigation, Vifor and American Regent have reached agreements with Viatris’ Mylan and Sandoz regarding their generic ferric carboxymaltose products, allowing both companies to bring rivals to market ahead of the expiry of certain US patents.
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