11 May | US | Alvotech filed a federal lawsuit against AbbVie in the US District Court of the Eastern District of Virginia, seeking to clear patent barriers relating to its biosimilar adalimumab, AVT02. Alvotech alleges that AbbVie has sought to protect its product monopoly by ‘overwhelming’ Alvotech with 60+ patent claims with questionable validity. Specifically, Alvotech alleges that AbbVie has acted improperly by:
- ‘patenting purported inventions that it does not use in the production of Humira®
- seeking multiple patents on the same invention but as part of different patent families in a manner designed to cause confusion;
- obtaining patents through inequitable conduct;
- by seeking patents that cover Humira® already in the prior art; and
- obtaining patents on purported inventions that AbbVie did not invent.‘
AbbVie’s Humira® still holds a market monopoly in the US, despite biosimilars being available in the EU, Japan, Canada and Australia.
12 May 21 | UK | The UK’s Medicine and Healthcare products Regulatory Agency (MHRA) finalised its ‘Guidance on the licensing of biosimilar products‘, outlining the licensing requirements for biosimilars in the post-Brexit UK. The MHRA had previously foreshadowed in its draft guidance that comparative efficacy/safety trials would not be necessary for most biosimilars. The MHRA has maintained its position in this finalised guidance, stating that ‘Although each biosimilar development needs to be evaluated on a case by case basis, it is considered that, in most cases, a comparative efficacy trial may not be necessary if sound scientific rationale supports this approach.‘.
14 May 21 | AU | Alphapharm received approval for Hulio® (biosimilar adalimumab) in Australia. Hulio® was approved in a 20mg/0.4mL solution for pre-filled syringe, 40mg/0.8mL solution for pre-filled syringe, and 40mg/0.8mL solution for pre-filled pen. Viatris launched Hulio® in Canada and Japan in February this year.
14 May 21 | Sarcoidosis News reported a new study demonstrates that patients with sarcoidosis can safely switch from Remicade® (infliximab) or Inflectra® (biosimilar infliximab) to Flixabi® (biosimilar infliximab) and maintain similar clinical benefits. Infliximab is not indicated for sarcoidosis, but is commonly used off-label and has been shown to improve lung function in refractory patients.