BioBlast w/e 27 Oct 23

Sanofi announced that it will separate its Consumer Healthcare Business as soon as the end of Q4 2024, creating a publicly listed company headquartered in France.  Sanofi intends to focus on its biopharma business.

The Department of Health and Aged Care has published the public summary documents considered at the July 2023 PBAC meeting.  Documents include:

• Cipla’s public summary document for Ardalicip®, biosimilar to AbbVie’s Humira® (adalimumab), which was developed by Alvotech (AVT02);
• Juno Pharmaceuticals’ public summary document for Exarane™ and Exarane Forte™ (Sanofi’s Lovenox®) (enoxaparin); and
• Sun Pharma’s public summary document for Yonsa Mpred® (Janssen’s Zytiga®) (abiraterone and methylprednisolone).

Coherus BioSciences announced that the FDA has approved its Loqtorzi® (toripalimab) in combination with cisplatin and gemcitabine for the first-line treatment of adults with metastatic or recurrent locally advanced nasopharyngeal cancer (NPC), and as monotherapy for the treatment of adults with recurrent, unresectable, or metastatic NPC with disease progression on or after platinum-containing chemotherapy.

Coherus acquired toripalimab from Surface Oncology last month on 8 September 2023.

Roche announced that the FDA has approved Vabysmo® (faricimab) to treat a new indication: macular oedema following retinal vein occlusion.  The clinical trials demonstrated non inferiority against aflibercept (marketed by Bayer/Regeneron’s as Eylea®).  The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023.  The FDA accepted Roche’s sBLA for Vabysmo® (faricimab) for this indication on 9 May 2023, which is its third approved indication.

Vabysmo® was first FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.  Vabysmo® was first  FDA approved for treat wet age-related macular degeneration and diabetic macular oedema on 28 January 2022.

Samsung Biologics has announced its Q3/2023 financial results, demonstrating its highest ever quarterly consolidated revenue of ₩1.034T, marking an 18% increase from Q3 2023.  Samsung attributed this revenue hike to an increase in the operating rate of Plant 4 and a sales backlog, resulting in a projected over 20% annual growth in consolidated revenue.

Throughout the quarter, Samsung Biologics also expanded its strategic partnerships to a value of over 11.8B and includes “14 of the top 20 global pharmaceutical companies further solidifying the company’s position as a trusted CDMO partner”.

Samsung will also open its new Plant 5 by April 2025, which will add an extra 180,000L of capacity.

On 24 October 2023, Samsung Biologics announced that it and European VC firm Kurma Partners entered a strategic partnership to develop and manufacture biologics for Kurma’s companies.

FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.  FDA has approved Samsung Bioepis’ sBLA for Byooviz®, as an interchangeable biosimilar to Genentech’s Lucentis® (ranibiziumab) across all approved indications.  Byooviz® was developed by Biogen and is being supplied by Samsung Bioepis under a deal inked in 2019 covering the US, Canada, Europe, Japan and Australia.  Byooviz® was FDA approved on 20 September 2021 and launched in the US on 2 June 2022.

Samsung Biologics announced that it has entered a strategic agreement with European VC firm Kurma Partners to develop and manufacture biologics.  Samsung Biologics will provide chemistry, manufacturing, control and development services to Kurma’s companies under the multi-year deal.

On 18 September 2023, Samsung Biologics announced a new agreement with Bristol Myers Squibb for large-scale manufacturing of a BMS antibody cancer drug.

Roche, Genentech, Chugai and Biogen have settled their dispute in the US District Court for the District of Massachusetts regarding Genentech’s Actemra® (tocilizumab) patents.  Roche, Genentech and Chugai instigated proceedings on 23 July 2023, alleging that Biogen’s product, manufactured in China by Bio-Thera, infringed 20 US patents including US patent No 7521052 (method of treating rheumatoid arthritis) and US patent No 8398980 (IL-6R antibody subtype).

Biogen received FDA approval for Tofidence®, its biosimilar to Roche’s Actemra®/ RoActemra® on 30 September 2023, the only approved biosimilar tocilizumab in the US.