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BioBlast w/e 11 Nov 22: Dupixent® recommended by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar approved, Alvotech’s adalimumab IC data, Mylan’s IPR win against Regeneron aflibercept patents, MHRA biosimilars guidance, Amgen biosimilars data, Coherus’ ranibizumab

by | Nov 14, 2022

Significant biosimilar activities this week include:

11 Nov 22 | EU | CHMP recommends Dupixent® (dupilimab) for prurigo nodularis

The CHMP recommended the approval of Dupixent® (dupilumab) for the treatment of moderate-to-severe prurigo nodularis who are candidates for systemic therapy.

11 Nov 22 | TME Pharma publishes data from Ph I/II trials of NOX-A12 with radiotherapy and bevacizumab

TME Pharma announced the publication of interim data from Ph I/II clinical trials of NOX-A12 (PEGylated L-stereoisomer RNA aptamer that targets CXCL12) combined with radiotherapy and bevacizumab biosimilar in first-line MGMT unmethylated brain cancer.  A poster presentation containing additional and updated data will be presented at the Society for Neuro-Oncology Annual Meeting on 18 November 2022.

10 Nov 22 | CN | First global denosumab biosimilar approved in PRC for Luye Pharma/Boan Biotech

China’s NMPA approved Luye Pharma subsidiary Boan Biotech’s Boyoubei® (denosumab biosimilar) for the treatment of postmenopausal women with osteoporosis at high risk of fractures.  Boyoubei® is the first biosimilar to Prolia® (the originator of denosumab) approved for marketing anywhere in the world.  Boan Biotech is developing Boyoubei for global sale.

10 Nov 22 | Alvotech to present data from adalimumab IC switching studies

Alvotech announced that it will present two posters (and will be featured in an Ignite Talk) related to its switching study for ATV02 (100mg/mL citrate-free biosimilar adalimumab) at the American College of Rheumatology (ACR) Convergence Conference, in Philadelphia on November 10-14, 2022.  Alvotech is the only known company that has both developed a high-concentration biosimilar candidate to Humira and completed a switching study to support potential regulatory approval as an interchangeable product.  Alvotech’s application for AVT02 was accepted in February 2022.

09 Nov 22 | US | PTAB invalidates two Regeneron aflibercept patents

PTAB issued decisions in Mylan’s IPR challenges relating to Regeneron’s 9,254,338 and 9,669,069 relating to Eylea® (aflibercept),  invalidating all claims the subject of the Mylan challenge, for anticipation.  Mylan’s IPRs were heard by PTAB in August 2022.  Regeneron filed a complaint against Mylan in West Virginia on 03 August 2022, alleging infringement of twenty-four patents – including the 2 subject patents – relating to Eylea® (aflibercept).

08 Nov 22 | US | Coherus’ Cimerli™ (biosimilar ranibizumab) achieves leading biosimilar market share in the US

Coherus Biosciences provided a business update, announcing that Cimerli™ (biosimilar ranibizumab) has achieved leading biosimilar market share in the US within the first four weeks of launch, with 2023 net sales expected to exceed $100 million.  Coherus’ net revenue for the quarter ending September 2022 was $45.4 million, down from $82.5 million for the quarter ending September 2022.  Coherus attributed this decline to a decrease in the sales of Udencya® (pegfilgrastim biosimilar) as well as a lower net realized price due to increased competition.

07 Nov 22 | Amgen to present data on biosimilars portfolio at ACRC

Amgen announced that it will present data across its portfolio at the American College of Rheumatology Convergence on 10-14 November 2022, including data for Amgevita® (biosimilar adalimumab), Enbrel® (biosimilar etanercept) and Prolia® (biosimilar denosumab).

07 Nov 22 | UK | MHRA updates 2021 biosimilars guidance

The MHRA has updated its guidance on the licensing of biosimilars to allow interchangeability between biosimilars to the same reference product at the prescriber level.  The MHRA’s position on pharmacy substitution (not allowed) remains unchanged.  This follows a similar move by the EMA in September 2022.

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