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Pearce IP BioBlast®: w/e 21 May 2021

by | May 24, 2021

12 May 21 | 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, omalizumab and denosumab candidates remain in Ph III trials.

17 May 21 | Sandoz Canada launched Inclunox® (biosimilar enoxaparin sodium) in Canada.

18 May 21 | 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 similar moves from Alberta, New Brunswick and British Columbia.

18 May 21 | Prestige BioPharma announced it has entered into a memorandum of understanding with the Busan City Government for the establishment of a R&D centre in Busan, South Korea.  Prestige announced that the 45,000 m2 centre will house 209 new R&D personnel for the next five years.  Prestige also announced that it has completed Ph III trials of its proposed trastuzumab biosimilar, and an application is currently under EMA review.

18 May 21 | The US Supreme Court declined to hear Novartis’ appeals against a lower court decision which upheld two Amgen patents relating to Enbrel® (etanercept).  Keren Haruvi, President of Sandoz US and Head of North America estimates that a biosimilar etanercept in the US could have saved payees USD$1 billion annually.

20 May 21 | US | The US House of Representatives Committee on Oversight and Reform published a Drug Pricing Investigation Staff Report which was scathing regarding AbbVie’s conduct regarding the sale of its blockbuster drugs Humira (adalimumab) and Imbruvica (ibrutinib) in pursuing ‘a variety of tactics to increase drug sales while raising prices for Americans, including exploiting the patent system to extend its market monopoly, abusing orphan drug protections to further block competition, and engaging in anti-competitive pricing practices.’. 

20 May 21 | Meiji Seika Pharma announced its Ph I trials of DMB-3115 (proposed ustekinumab) biosimilar demonstrated the bioequivalence of its product to the reference product.






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