AstraZeneca announced that the EMA has approved Soliris® (eculizumab) for a new indication: treatment of refractory generalised myasthenia gravis (gMG) in children and adolescents aged six to 17 years who are anti-acetylcholine receptor (AChR) antibody-positive. Soliris® is the first and only targeted therapy approved for the treatment of paediatric patients with the disease in the EU. The company also confirmed that regulatory submissions for Soliris® for the treatment of paediatric patients with gMG are currently ongoing or planned with various health authorities.
The approval follows the CHMP recommendation for approval of the new indication on 26 June 2023.
According to the Korea Biomedical Review Celltrion has applied to the Ministry of Food and Drug Safety for marketing authorisation of its CT-P42, biosimilar to Regeneron’s Eylea® (aflibercept) for all of Eylea®’s indications approved in Korea, including wet age-related macular degeneration and diabetic macular edema.
Celltrion announced the results of its Ph III trials of CT-P42 on 3 April 2023 which demonstrated equivalence and similarity to Eylea®. CT-P42 met secondary endpoints of efficacy, safety, and immunogenicity when compared with Regeneron’s Eyela®.
On 30 June 2023, Celltrion filed an NDA for CT-P42 with the FDA, and announced that it intends to file an ABLA in at least the US and Europe later in 2023.
STADA and Xbrane announced that their commercialization agreement with Bausch + Lonb has been terminated, and that they are considering options for their co-developed ranibizumab biosimilar to Genentech’s Lucentis® (Ximluci®) in North America.
Xbrane entered into a co-development agreement with STADA Arzneimittel AG in 2018, and subsequently, in May 2020, the two companies signed an exclusive licensing agreement with Bausch + Lomb to bring the biosimilar candidate to market in the United States and Canada.
After receiving EU approval in November 2022, STADA and Xbrane intend to commercialise the product in the US. On 22 June 2023, Xbrane announced the FDA has accepted a supplemental Biologics License Application (sBLA) for (Ximluci®).
The expansion to the existing strategic partnership relates to exclusive commercialisation in the US by Teva of two new biosimilar candidates and line extensions of two current biosimilar candidates in the partnership, to be developed, and manufactured by Alvotech. The existing partnership includes: two US biosimilar candidates pending FDA approval:
AVT02 (adalimumab), an interchangeable high-concentration biosimilar to AbbVie’s Humira®; and
AVT04 (ustekinumab) biosimilar to Janssen’s Stelara®
The agreement also covers milestone payments and shared profits from the commercialization of the biosimilars. All other terms of the expansion remain confidential.
The partnership was entered into between Alvotech and Teva on 5 August 2020. On 6 January 2023, the two companies announced that the FDA accepted for review their BLA for AVT04, and on 12 June 2023 they reached a settlement and license agreement with Johnson & Johnson for AVT04.
On 12 June 2023, Alvotech and Teva reached a settlement and licence agreement with J&J regarding AVT04 (ustekinumab), biosimilar to Janssen’s Stelara®.
A Sandoz/Bio-Thera comparability study has demonstrated similarity between BAT1706 (bevacizumab) and Genentech’s Avastin® (bevacizumab) in terms of all physicochemical and functional attributes.
BAT1706 is currently under regulatory review by the FDA (BLA accepted on 18 January 2021) and the EMA (MA submitted on 26 November 2020). BAT1706 has already been approved in China and is being supplied as Pobevcy®.
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Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is market leading in the field of pharma/biopharma, biotechnology and animal health.
Underpinning Naomi's legal work is a deep understanding of the pharma/biopharma industries, resulting from 25 years' experience including as VP of IP in-house global pharma giants, Partner of a top-tier international law firm, and as the founding Principal of Pearce IP.