Pearce IP BioBlast® w/e 10 December 2021

by , | Dec 13, 2021

06 Dec 21 | AU | Australia’s TGA provisionally approved Celltrion’s Regkirona® (regdanvimab) for the treatment of adults with coronavirus who do not require supplemental oxygen and are at increased risk of progressing to severe COVID-19.

07 Dec 21 | Alvotech and Oaktree Acquisition Corp. II announced that they have entered into a merger agreement for the creation of a publicly-traded global biopharmaceutical company. Alvotech is led by a team of highly experienced biopharma leaders, including Mark Levick as CEO, Anil Okay as CCO, and Philip Caramanica as Chief IP Counsel and Deputy General Counsel. The merger is expected to deliver gross proceeds to Alvotech in excess of USD$450 million.  Alvotech currently has seven products in its pipeline, including a biosimilar candidate to Humira® (adalimumab), Stelara® (ustekinumab), Eylea® (aflibercept), Prolia®/Xgeva® (denosumab) and Simponi®/Simponi ARIA® (golimumab).

07  Dec 21 | Prestige BioPharma announced that its Ph I study of PBP1502 (proposed adalimumab biosimilar) has been registered with the US National Institute of Health.  Prestige disclosed that it plans to file marketing authorisation applications with the EMA and FDA in 2023.

08 Dec 21 | Samsung Bioepis announced that its Ontruzant® (biosimilar trastuzumab) demonstrated comparable long-term survival results with reference trastuzumab in five-year follow-up results.

09 Dec 21 | MoneyControl reported that Biocon and Mylan are in advanced talks for the creation of a biosimilars spin-off. To date neither party has confirmed these this speculation.

09 Dec 21 | US | Hikma Pharmaceuticals and Gedeon Richter announced that they have entered into an exclusive license agreement to commercialise Gedeon Richter’s proposed denosumab biosimilar in the United States.

09 Dec 21 | Dr Reddy’s and Prestige BioPharma announced that they have entered into an exclusive partnership for the supply and commercialisation of Prestige BioPharma’s proposed trastuzumab biosimilar in select countries in Latin America and Southeast Asia.

10 Dec 21 | Novartis CEO Vas Narasimhan announced that the potential sale of Sandoz has attracted interest from potential buyers.  Novartis is expected to decide the future of Sandoz by the end of 2022.

Pearce IP offers Australian based, generics and biosimilars focused lawyers, attorneys and regulatory affairs experts, with incomparable global experience, technical competence, and commercial elegance.  Call us today on 02 9023 9988 or email

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