BioBlast® w/e 28 Oct 22: Expanded indications in CA for Roche’s tocilizumab, AU PBAC outcomes, Alvotech financial results, Biogen seeks PI against Sandoz in natalizumab dispute, JSR/Similis Bio agreement, Regeneron/Mylan expedited aflibercept hearing, Genentech trade secrets sentencing

by , | Oct 31, 2022

Significant biosimilar activities this week include:

28 Oct 22 | Health Canada approves additional COVID-19 indication for Actemra® IV (tocilizumab)

Roche Canada announced that Health Canada has approved Actemra® IV (tocilizumab) for the treatment of hospitalised adult patients with COVID-19 who are receiving systemic corticosteroids, and require supplemental oxygen, non-invasive or invasive mechanical ventilation or extracorporeal membrane oxygenation.

28 Oct 22 | AU | PBAC public summary documents published

The Australian Pharmaceutical Benefits Advisory Counsel (PBAC) published the public summary documents from its July 2022 meeting.  Among the updates were:

  • Yuflyma® (adalimumab): recommended with ‘a-flagged’ status for the same indications as Humira®.
  • Tysabri® (natalizumab): amended listings (removing a requirement for neurologists prescribing natalizumab to be registered with the Tysabri Australian Prescribing Program) recommended by PBAC.
  • Epidyolex® (cannabidiol): not recommended for the treatment of Lennox-Gastaut syndrome, as the incremental cost effectiveness ratio was deemed to be unacceptably high at the price proposed.
  • Keytruda® (pembrolizumab): amended listings (increasing the max number of repeats, and maximum number of cycles in a lifetime) recommended by PBAC.
  • Stelara® (ustekinumab): vial for IV infusion and PFS recommended for the treatment of moderate to severe ulcerative colitis. 90mg/1mL PFS recommended for the treatment of Crohn disease and severe chronic plaque psoriasis.

27 Oct 22 | Alvotech to report first nine months financial results

Alvotech announced that it will release financial results for the first nine months of 2022 on 15 November 2022.  Following the release, Alvotech will conduct a business update conference call and live webcast.

27 Oct 22 | US | Biogen seeks interlocutory injunction in natalizumab dispute

Biogen is seeking a preliminary injunction in its proceedings against Sandoz commenced in September 3033 relating to natalizumab.  Biogen and Sandoz filed a joint stipulation and proposed schedule, seeking a preliminary injunction after 07 April 2023.  Biogen filed a sealed complaint against Sandoz and Polpharma in September 2022, alleging infringement of 28 Biogen patents.

27 Oct 22 | Merck Third Quarter 2022 Financial Results

Merck announced its third quarter 2022 financial results on 27 October.  Worldwide sales for the quarter were $15.0 billion, an increase of 14% from third quarter 2021.  $5.4 billion of this was attributable to KEYTRUDA® (pembrolizumab), sales for which had grown 20% over third quarter 2021.

25 Oct 22 | JSR and Similis Bio sign development and licence agreement for four biosimilars

JSR Life Sciences announced that its recently launched biosimilars business Similis Bio has entered into a development and licence agreement with Blau Farmaceutica for four biosimilar products targeting oncology, inflammation and blood disorders.  Under the agreement, Similis Bio will provide full processes and associated IP for tech transfer to Blau; and Blau will use the licensed IP for GMP manufacturing and clinical development, and seek regulatory approval.  JSR disclosed the global market value of these 4 products is USD 42B.

25 Oct 22 | US | Regeneron v Mylan aflibercept trial set for June 2023

A trial date of 12 – 23 June 2023 has been set in the Regeneron v Mylan aflibercept District Court (NDWV) BPCIA dispute.  Regeneron has identified 6 patents from 3 patent families for initial proceedings, and has stipulated that it will not seek injunctive relief on the other 18 patents asserted in its complaint.  This hearing date will be a mere eight months after Regeneron filed a complaint against Mylan in August 2022. Mylan filed it’s a-BLA for biosimilar aflibercept in October 2021, and received FDA notification that the application was accepted on 28 December 2021.

18 Oct 22 | Sentences handed down in Genentech secrets case

Former Genentech scientist Xanthe Lam and her husband Allen Lam were each sentenced to six months imprisonment and fines of over $10,000 for their role in the Genentech/JHL Biotech trade secrets scandal.  The Lams plead guilty to stealing confidential intellectual property relating to Genentech’s Rituxan® (rituximab), Herceptin® (trastuzumab) and Avastin® (bevacizumab), passing the information onto JHL Biotech to aid in its biosimilar development.

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