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Henlius to present new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar)
Henlius announced that it will present the results of new studies on serplulimab (anti-PD-1 mAb) and HLX04 (bevacizumab biosimilar) at the 24th Annual Meeting of Chinese Society of Clinical Oncology (CSCO).
EU | EU’s CHMP recommends the approval of AVT02 (proposed adalimumab biosimilar)
Alvotech announced that the EU’s CHMP has adopted a positive opinion recommending the approval of AVT02 (proposed adalimumab biosimilar).
AbbVie and REGENXBIO announce new partnership to develop and commercialise RGX-314
AbbVie and RegenXBio announced a partnership to develop and commercialise RGX-314 (proposed one-time gene therapy for the treatment of wet age-related macular degeneration, diabetic retinopathy and other chronic retinal diseases).
Samsung Bioepis releases new data on five-year follow-up study of Ontruzant® (trastuzumab biosimilar)
Samsung Bioepis reported on a five-year follow-up study comparing ONTRUZANT® (trastuzumab biosimilar) with reference trastuzumab in early or locally advanced HER2 positive breast cancer. Samsung Bioepis reported that five year survival rates were 93.1% in the biosimilar trastuzumab group compared with 86.7% in the reference medicine group.
AU | Australia’s TGA approves Kyowa Kirin’s Crysvita® (burosumab)
Australia’s TGA approved Kyowa Kirin’s Crysvita® (burosumab) for the treatment of X-linked hypophosphataemia.
Alvotech announces positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®
Alvotech announced positive top-line results from its switching study between AVT02 (proposed adalimumab biosimilar) and Humira®. Alvotech reported that no significant differences were observed in clinical efficacy, safety or immunogenicity between the switching cohort and the reference cohort.
BioFactura and Rani Therapeutics enter into agreement relating to proposed ustekinumab biosimilar
BioFactura announced it has reached an agreement with Rani Therapeutics to assess BFI-751 (proposed ustekinumab biosimilar) in combination with the RaniPill® platform. The RaniPill® capsule is intended to replace subcutaneous or IV injection of biologics with oral dosing.
Samsung Bioepis announces new data from Ph III clinical study of Byooviz® (ranibizumab biosimilar)
Samsung Bioepis announced results from a post-hoc and subgroup analysis of a Ph III clinical study of Byooviz® (ranibizumab biosimilar). Samsung Bioepis reported that the data supports biosimilarity between Byooviz® and reference ranibizumab.
CA |EU |US | Bio-Thera Solutions and Sandoz enter into agreement for bevacizumab biosimilar
Bio-Thera Solutions announced that it has entered into a commercialisation and license agreement with Sandoz to commercialise BAT1706 (proposed bevacizumab biosimilar). Under the agreement, Sandoz will commercialise the product in the US, Europe, Canada and other international markets in exchange for an upfront payment, potential milestone payments and royalties on product sales.
Adaptimmune Therapeutics and Genentech enter into strategic collaboration
Adaptimmune Therapeutics announced it has entered into a strategic collaboration and license agreement with Genentech to develop and commercialise allogeneic cell therapies for multiple oncology indications.
Fresenius Kabi releases new data on MSB11456 (proposed biosimilar tocilizumab)
Fresenius Kabi announced that its biosimilar tocilizumab candidate MSB11456 successfully met its primary and secondary endpoints in Ph I trials of both subcutaneous and intravenous formulations.
AU | Australia’s TGA approves Gilead Sciences’ Trodelvy® (sacitizumab)
Australia’s TGA approved Gilead Sciences’ Trodelvy® (sacitizumab) for the treatment of unresectable locally advanced or metastatic triple-negative breast cancer.
AU | Australia’s TGA approves Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab)
Australia’s TGA approved Mylan/Alphapharm’s Abevmy® (biosimilar bevacizumab) for the treatment of colorectal cancer, breast cancer, non-small cell lung cancer, renal cell cancer, epithelial ovarian, fallopian tube, peritoneal cancer and cervical cancer.
IN | Hetero receives emergency use approval in India for tocilizumab
Hetero announced that it has received emergency use approval from India’s DCGI to market its biosimilar tocilizumab for the treatment of COVID-19.
Dr Reddy’s sells E7777 (an engineered IL-2-diptheria toxin fusion protein) rights to Citius Pharmaceuticals
Dr Reddy’s announced that it has sold all of its rights to E7777 (an engineered IL-2-diptheria toxin fusion protein) to Citius Pharmaceuticals. Under the agreement, Dr Reddy’s will receive $40 million upfront, and milestone payments of up to $40 million (related to the cutaneous T-cell lymphoma indication) and $70 million (additional indication approvals).
CN | China’s NMPA approves JW Therapeutics’ Relma-cel (relmacabtagene autoleucel)
China’s NMPA approved JW Therapeutics’ Relma-cel (relmacabtagene autoleucel) for the treatment of large B-cell lymphoma.
UK | The UK’s NICE recommends Novartis’ Cosentyx® (secukinumab)
The UK’s NICE recommended Novartis’ Cosentyx® (secukinumab) as a treatment for plaque psoriasis in children aged 6-17 years.
US | Amgen and Hospira ready to settle Neupogen® (filgrastim) dispute
Amgen and Hospira appear ready to settle the ongoing dispute relating to Neupogen® (filgrastim). The matter was due to go to a jury trial on 20 September 2021.
EU | The UK’s NICE recommends UCB Pharma’s Bimzelx® (bimekizumab)
The UK’s NICE recommended UCB Pharma’s Bimzelx® (bimekizumab) as a treatment for plaque psoriasis in adults.
AU | AU’s TGA approves Celgene’s Reblozyl® (luspatercept)
Australia’s TGA approved Celgene’s Reblozyl® (luspatercept) for the treatment of transfusion-dependent anaemia.
IN | India’s DCGI approves Enzene’s biosimilar denosumab
India’s DCGI granted marketing authorisation for Enzene Bioscience’s biosimilar denosumab.
US | Bio-Thera and Hikma sign commercialisation agreement for ustekinumab biosimilar
Bio-Thera Solutions and Hikma Pharmaceuticals announced that they have signed an exclusive commercialisation and license agreement for BAT2206 (proposed ustekinumab biosimilar). Under the agreement, Hikma will gain exclusive commercialisation rights in the US with a first-right-to-negotiate to add Europe (excluding CIS countries) to the agreement.
US | Two former JHL Biotech executives plead guilty to conspiracy to steal trade secrets and commit wire fraud exceeding $101 million
Two former executives of JHL Biotech plead guilty to conspiracy to steal trade secrets and commit wire fraud exceeding $101 million in the US District Court for the Northern District of California. The written plea agreements disclosed that the executives used confidential, proprietary and trade secret information from Genentech to accelerate the timeline and reduce the costs of JHL Biotech’s development and production of Genentech biosimilars.
US | US District Court refuses to dismiss AbbVie’s Humira® infringement suit
The US District Court for the Northern District of Illinois refused to dismiss AbbVie’s Humira® (adalimumab) infringement suit against Alvotech hf. The court found that AbbVie is not required to sue the US based subsidiary listed on the aBLA form, but could sue Icelandic company Alvotech hf.
Product specific reports based on extracts from our BioBlast® database
BioBlast® Editor and Contributing Author
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