The Government of Quebec announced it would introduce a biosimilar switching program which is expected to generate annual savings of more than CAD$100 million. All patients in Quebec currently on biologics must switch to a biosimilar by April 12, 2022. This follows simila...
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 a...
On 11 May 2021, Treasurer Josh Frydenberg announced that the 2021-2022 Australian Federal Budget would introduce a Patent Box tax break. This regime is designed to encourage domest...
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...
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...
Celltrion released its Q1 2020 financial results, reporting that YoY sales of Celltrion biosimilars increased by 23%. Celltrion announced that it is planning to complete Ph III trials of biosimilar bevacizumab in the first half of 2021, and that ustekinumab, aflibercept, o...
IP waivers alone are nowhere near enough to increase COVID-19 vaccine access for developing countries, but US support for such waivers will create enormous pressure on existing manu...
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 dr...
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 proposed biosimilar adalimumab, AVT02. Alvotech alleges that AbbVie has sought to protect its product monopoly by R...
Pearce IP publishes free e-books addressing various aspects of patent law and practice in Australia, with a focus on issues affecting pharmaceutical, biopharmaceutical and other life sciences companies.
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