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BioBlast w/e 04 Nov 22: dupilumab study, Accord cleans up at Global Generics and Biosimilars Awards, Amgen’s Supreme Court petition for certioriari regarding enablement granted, AU tocilizumab COVID shortage measures lifted, Bio-Thera’s secukinumab, Outlook’s ophthalmic bevacizumab, Rani Therapeutics’ oral ustekinumab

by | Nov 7, 2022

Significant biosimilar activities this week include:

04 Nov 22 | New dupilumab study suggests serum dupilumab levels are not associated with treatment response or adverse effects in AD patients

A new study involving 295 patients with AD published in JAMA reported that there is no association between serum dupilumab and treatment response and adverse effects in atopic dermatitis during the first year of treatment.

03 Nov 22 | US | Supreme Court grants Amgen’s petition for certiorari in patent proceedings against Sanofi/Regeneron (alirocumab)

On Friday, the US Supreme Court granted Amgen’s petition for certiorari in relation to ‘whether enablement is governed by the statutory requirement that the specification teach those skilled in the art to “make and use” the claimed invention, 35 U.S.C. §112, or whether it must instead enable those skilled in the art “to reach the full scope of claimed embodiments” without undue experimentation—i.e., to cumulatively identify and make all or nearly all embodiments of the invention without substantial “‘time and effort,’”. This petition was filed in response to the Federal Court decision which invalidated genus claims in two Amgen patents relating to Repatha® (evolocumab) which it asserted against Sanofi/Regeneron regarding Praluent® (alirocumab).

02 Nov 22 | Accord cleans up at 2022 Global Generics and Biosimilars Awards

Accord Healthcare was the clear winner at the Global Generics and Biosimilars Awards which were presented on 2 November in Frankfurt, achieving “Biosimilar Initiative of the Year”, “Company of the Year”, “Value Added Medicine Initiative of the Year”, and “Regulatory Achievement of the Year”.  Dr Reddy’s, Samsung Bioepis, Stada and Shanghai Henlius Biotech were also winners in the following categories:

  • Dr Reddy’s Laboratories: Company of the Year, Americas;
  • Samsung Bioepis: Company of the Year, Asia-Pacific;
  • Stada: Intellectual Property Strategy of the Year; and
  • Shanghai Henlius Biotech: BD of the year.

01 Nov 22 | AU | PBAC lifts tocilizumab shortage measures

Australia’s PBAC reversed the temporary COVID measures put in place in response to drug shortages during the COVID pandemic allowing patients to transition off tocilizumab during the shortage period to another biological disease modifying drug (bDMARD) claiming that “as of 15 July 2022, the supply shortage of tocilizumab has resolved”.  From 01 December 2022, these items will move to a ‘Supply Only’ state for six months (allowing patients to fill outstanding repeats on prescriptions), before being completely removed from the PBS.

01 Nov 22 | Bio-Thera Solutions commences Ph III trials of Novartis’ secukinumab (Cosentyx®)

Bio-Thera Solutions announced that it has commenced Ph III trials of BAT2306, biosimilar to Novartis’ secukinumab (Cosentyx®) in patients with moderate to severe plaque psoriasis.

28 Oct 22 | US | FDA accepts Outlook Therapeutics BLA for ONS-5010 (ophthalmic bevacizumab biosimilar)

Outlook Therapeutics announced that the FDA has accepted its BLA for ONS-5010 (ophthalmic bevacizumab biosimilar) for the treatment of wet age-related macular degeneration. The FDA has set a PDUFA goal date of 29 August 2023.

24 Oct 22 | Rani Therapeutics developing oral ustekinumab

Rani Therapeutics announced that it has commenced preclinical development of RT-111 a RaniPill GO capsule containing an ustekinumab biosimilar.  BioFactura and Rani Therapeutics entered into an agreement in September 2021 to assess Bio-Thera’s BFI-751 (ustekinumab biosimilar) in combination with Rani’s RaniPill® platform.

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