BioBlast w/e 11 Nov 22: Dupixent® beneficial by CHMP, TME Pharma’s NOX-A12, World first denosumab biosimilar authorized, Alvotech’s adalimumab IC knowledge, Mylan’s IPR win towards Regeneron aflibercept patents, MHRA biosimilars steering, Amgen biosimilars knowledge, Coherus’ ranibizumab

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Important biosimilar actions this week embody:

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

The CHMP beneficial the approval of Dupixent® (dupilumab) for the remedy of moderate-to-severe prurigo nodularis who’re candidates for systemic remedy.

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

TME Pharma introduced the publication of interim knowledge from Ph I/II scientific trials of NOX-A12 (PEGylated L-stereoisomer RNA aptamer that targets CXCL12) mixed with radiotherapy and bevacizumab biosimilar in first-line MGMT unmethylated mind most cancers. A poster presentation containing extra and up to date knowledge might be introduced on the Society for Neuro-Oncology Annual Assembly on 18 November 2022.

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

China’s NMPA authorized Luye Pharma subsidiary Boan Biotech’s Boyoubei® (denosumab biosimilar) for the remedy of postmenopausal girls with osteoporosis at excessive danger of fractures. Boyoubei® is the primary biosimilar to Prolia® (the originator of denosumab) authorized for advertising wherever on the earth. Boan Biotech is growing Boyoubei for world sale.

10 Nov 22 | Alvotech to current knowledge from adalimumab IC switching research

Alvotech introduced that it’ll current two posters (and might be featured in an Ignite Speak) associated to its switching research for ATV02 (100mg/mL citrate-free biosimilar adalimumab) on the American School of Rheumatology (ACR) Convergence Convention, in Philadelphia on November 10-14, 2022. Alvotech is the one identified firm that has each developed a high-concentration biosimilar candidate to Humira and accomplished a switching research to assist potential regulatory approval as an interchangeable product. Alvotech’s software for AVT02 was accepted in February 2022.

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

PTAB issued selections in Mylan’s IPR challenges regarding Regeneron’s 9,254,338 and 9,669,069 regarding Eylea® (aflibercept), invalidating all claims the topic of the Mylan problem, for anticipation. Mylan’s IPRs had been heard by PTAB in August 2022. Regeneron filed a grievance towards Mylan in West Virginia on 03 August 2022, alleging infringement of twenty-four patents – together with the two topic patents – regarding Eylea® (aflibercept).

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

Coherus Biosciences supplied a enterprise replace, saying that Cimerli™ (biosimilar ranibizumab) has achieved main biosimilar market share within the US throughout the first 4 weeks of launch, with 2023 web gross sales anticipated to exceed $100 million. Coherus’ web income 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 lower within the gross sales of Udencya® (pegfilgrastim biosimilar) in addition to a decrease web realized value on account of elevated competitors.

07 Nov 22 | Amgen to current knowledge on biosimilars portfolio at ACRC

Amgen introduced that it’ll current knowledge throughout its portfolio on the American School of Rheumatology Convergence on 10-14 November 2022, together with knowledge for Amgevita® (biosimilar adalimumab), Enbrel® (biosimilar etanercept) and Prolia® (biosimilar denosumab).

07 Nov 22 | UK | MHRA updates 2021 biosimilars steering

The MHRA has up to date its steering on the licensing of biosimilars to permit interchangeability between biosimilars to the identical reference product on the prescriber degree. The MHRA’s place on pharmacy substitution (not allowed) stays unchanged. This follows the same transfer by the EMA in September 2022.

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