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BioBlast® w/e 27 Jan 23: Alvotech Simlandi® (biosimilar adalimumab) approval, Alvotech completes private placement round, PTAB institutes Mylan aflibercept challenges, Dr Reddy’s rituximab, BeiGene’s denosumab, MHRA grants Ximluci® (biosimilar ranibizumab) marketing authorisation, NMPA approves BAT1806 (biosimilar tocilizumab), Genentech and Tanvex settlement, Luye Pharma denosumab

by | Jan 30, 2023

Significant biosimilar activities this week include:

24 Jan 23 | Saudi Food & Drug Authority approves Alvotech’s Simlandi® (biosimilar adalimumab)

Alvotech and Bioventure announced that the Saudi Food & Drug Authority has approved the manufacture and distribution of Simladi™ (AVT02, biosimilar adalimumab).  Bioventure, is a wholly owned subsidiary of GlobalOne Healthcare Holding LLC, the healthcare division of Yas Holding LLC, and is Alvotech’s exclusive strategic partner for the commercialisation of Simlandi in the Middle East and North Africa.

23 Jan 23 | Alvotech completes private placement of approx. USD $137 million

Alvotech announced the completion of a private placement of approximately USD$137 million of its ordinary shares, at a purchase price of $11.57 per share.  Alvotech reported that the shares are expected to be delivered from previously issued treasury shares held by Alovtech’s subsidiary, Alvotech Manco ehf.  The private placement was initiated on 19 January 2023 and completed on 22 January 2023.

20 Jan 23 | US | PTAB institutes aflibercept challenges

PTAB instituted two IPR petitions filed by Mylan challenging Regeneron’s US10,130,681 and US10,888,601 patents, which relate to Eylea® (aflibercept).  PTAB found that Mylan demonstrated a reasonable likelihood that at least claim 1 of the ‘681 patent and claim 34 of the ‘601 patent is unpatentable as being anticipated by the same piece of prior art.  A third Mylan IPR challenge, to Regeneron’s US10,857,205 is likely to be initiated in April 2023.

20 Jan 23 | Dr. Reddy’s preparing to file BLA/MAA dossiers for rituximab biosimilar

Dr. Reddy’s announced that it has successfully completed the full set of clinical studies of DRL_RI (proposed rituximab biosimilar) for filing in the US, EU and other regions against Roche/Biogen’s Rituxan®. DRL_RI will be commercialised by Fresenius Kabi in the US, and by Dr. Reddy’s directly in other jurisdictions.

18 Jan 23 | CN | NMPA expands coverage for BeiGene’s tislelizumab and Xgeva® (denosumab)

BeiGene announced that the National Reimbursement Drug List released by China’s NMPA has been updated to include four new indications for its PD-1 inhibitor tislelizumab.  BeiGene’s Xgeva® (denosumab) was also renewed in the NRDL.  These updates will take effect from 01 March 2023.

16 Jan 23 | UK | MHRA grants marketing authorisation for Ximluci® (biosimilar ranibizumab)

STADA and Xbrane announced that Ximluci® (ranibizumab, biosimilar to Roche/Genentech’s Actemra®) has been granted marketing authorisation by the MHRA. Under a July 2018 agreement, STADA and Xbrane are jointly responsible for development and manufacturing of Ximluci, while STADA holds the marketing authorisations and commercial rights to the product across all territories included in the agreement.

16 Jan 23 | CN | NMPA approves Bio-Thera’s BAT1806 (biosimilar tocilizumab)

Bio-Thera Solutions announced that China’s NMPA has approved BAT1806 (biosimilar tocilizumab) for the treatment of rheumatoid arthritis, systemic juvenile idiopathic arthritis, and cytokine release syndrome.

06 Jan 23 | US | Genentech and Tanvex reach agreement-in-principle in trastuzumab case

Genentech and Tanvex BioPharma filed a joint notice of settlement in the District Court of the Southern District of California, notifying the court that they have reached an agreement-in-principle to resolve all pending claims in relation to their dispute over Tanvex’s BLA submission for a biosimilar trastuzumab.  The parties stated that they expect the final executed Joint Stipulation of Dismissal of all claims will be filed within 30 days.

January 2023 | New study reports LY06006 might be effective in osteoporosis

A new study published in the Journal of Orthopaedic Translation reported that LY06006 (biosimilar denosumab) might be an effective treatment for osteoporosis.  The study also reported that LY06006 was generally safe and well tolerated without unexpected reactions, similar to Prolia® (denosumab).

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