Significant biosimilar activities this week include:

03 Dec 22 | Alvotech announces changes to share listings and leadership team

Alvotech announced that Nasdaq Iceland has approved its request for the admission of its shares on the Nasdaq Iceland Main Market under the ticket symbol ‘ALVO’. Alvotech became the first dual US-Icelandic listed company on 23 June 2022. Alvotech also announced changes to its leadership team, with CEO Mark Levick stepping down. Executive Chairman and founder, Robert Wessman will replace Mark Levick as CEO, with former Executive VP and Head of Global R&D at Teva, Dr Hafun Fridriksdottir to become Chief Operating Officer.

03 Dec 22 | Merck’s development of subcutaneous formulations of Keytruda® (pembrolizumab)

Reuters reported that Merck hopes to patent subcutaneous formulations of Keytruda® (pembrolizumab). Merck has several studies evaluating subcutaneous pembrolizumab planned or underway, according to a search of clinicaltrials.gov and a previous press release. A subcutaneous formulation may be more convenient for patients and healthcare providers, and therefore has the potential to replace the current infusion regime in many settings. Reuters reported that Merck CFO Caroline Litchfield stated that Merck believes such a formulation would be patentable, which could mean Merck’s patent protection for its blockbuster is extended for a considerable period of time. The report states that Merck is anticipating biosimilar competition for the infusion product by 2028.

30 Nov 22 | US | Janssen sues Amgen over ustekinumab biosimilar

Janssen sued Amgen in the District Court of Delaware in relation to Amgen’s ABP654 (biosimilar ustekinumab). Janssen alleges that Amgen’s product will infringe US patent Nos 6,902,734 (API) and 10,961,307 (methods of treating ulcerative colitis). Amgen released preliminary results from its Ph III trials of ABP654 in April 2022, and it has not yet been approved by the FDA.

30 Nov 22 | Erasca and Pierre Fabre sign agreement for encorafenib and cetuximab

Erasca announced it has signed a clinical trial collaboration and supply agreement with Pierre Fabre for BRAFTOVI (encorafenib) within key international territories. Erasca reported that this agreement will support a clinical proof-of-concept trial evaluating ERAS-007 (oral ERK1/2 inhibitor) in combination with encorafenib and cetuximab for the treatment of BRAF V600E-mutant metastatic colorectal cancer (mCRC).

29 Nov 22 | MENA | Hikma and Celltrion sign ustekinumab agreement

Hikma Pharmaceuticals announced that it has signed an exclusive licence agreement with Celltrion for CT-P43 (biosimilar ustekinumab). Under the agreement, Hikma will receive exclusive rights to market Celltrion’s product in all of Hikma’s MENA markets.

29 Nov 22 | US | Merck suit against The Johns Hopkins University’s for breach of contract regarding Keytruda® (pembrolizumab) patents

Merck has filed a complaint in the United States District Court (District of Maryland) against The Johns Hopkins University in relation to certain patents of the university relating to Keytruda® (pembrolizumab). Based on the wording of the complaint, the dispute arose out of a contract between Merck and the university to design and conduct a clinical trial on administration regimes for Keytruda® in cancer patients with certain genetic biomarkers. The complaint alleges that the university was issued four US patents in 2021 and 2022 that cite the joint study but that the university claimed the inventions arose prior to the study, and that it exclusively licensed the patents to others, demanding payment from Merck for use of Keytruda®. Merck is seeking from the court a declaration that the university breached the contract for the clinical trial, damages for breach of contract and declarations that Merck’s manufacture, use, sale offer for sale and/importation of Keytruda® do not infringe any of the patents in question.

29 Nov 22 | UK | MHRA warns of ocular adverse reactions to Dupixent® (dupimumab)

The MHRA updated its guidance on Dupixent® (dupilumab), warning of the risk of ocular adverse reactions. The MHRA reported that the potential for ocular adverse reactions was established during clinical trials, however further ocular adverse reactions have been identified during post-marketing clinical use.