Significant biosimilar activities this fortnight include:
13 April 2023 | US | Alvotech CRL provided to FDA regarding high concentration buffer free biosimilar adalimumab
12 April 2023 | AU | Samsung Bioepis files opposition to Janssen’s Stelara® patent application
10 April 2023 | SK | Celltrion announces safety and efficacy of omalizumab biosimilar CT-P39
10 April 2023 | UK | Approval alert: Scotland accepts Daiichi Sankyo’s Enhertu® (trastuzumab deruxtecan) to treat HER2-positive breast cancer
10 April 2023 | US | FDA to discuss full approval of LEQEMBI™ (lecanemab) on 9 June 2023
08 April 2023 | IN | Intas’ ranibizumab biosimilar similar efficacy and safety to Genentech’s Lucentis®
06 April 2023 | EU | Merck & Moderna announce mRNA-4157/V940/Keytruda® receives EMA PRIME Scheme Designation
05 April 2023 | US | FDA approves Accord’s BLA for trastuzumab, biosimilar to Genentech’s Herceptin®
03 April 2023 | Celltrion aflibercept biosimilar equivalent to Regeneron’s Eylea® in Ph III trials
03 April 2023 | EU | Further woes for AbbVie Humira® empire as EC grants MA for Sandoz’ adalimumab biosimilar Hyrimoz®
03 April 2023 | EU | STADA and Xbrane announce launch of ranibizumab biosimilar Ximluci®
01 April 2023 | US | Eli Lilly launches insulin glargine biosimilar Rezvoglar®
31 March 2023 | CN | Mabwell’s Mailishu® (denosumab), biosimilar to Amgen’s Xgeva®/Prolia® approved
27 March 2023 | JP | Takeda receives Japanese approval for subcutaneous Entyvio® (vedolizumab)
25 March 2023 | Study confirms infliximab biosimilar clinically equivalent to Janssen’s Remicade®
24 March 2023 | CA | More Canadian provinces implement biosimilar switching policies
Naomi Pearce
CEO, Executive Lawyer (AU, NZ), Patent & Trade Mark Attorney (AU, NZ)
Naomi is the founder of Pearce IP, and is one of Australia’s leading IP practitioners. Naomi is a market leading, strategic, commercially astute, patent lawyer, patent attorney and trade mark attorney, with over 25 years’ experience, and a background in molecular biology/biochemistry. Ranked in virtually every notable legal directory, highly regarded by peers and clients, with a background in molecular biology, Naomi is renown for her successful and elegant IP/legal strategies.
Among other awards, Naomi is ranked in Chambers, IAM Patent 1000, IAM Strategy 300, is a MIP “Patent Star”, and is recognised as a WIPR Leader for patents and trade marks. Naomi is the 2023 Lawyers Weekly “IP Partner of the Year”, the 2022 Lexology client choice award recipient for Life Sciences, the 2022 Asia Pacific Women in Business Law “Patent Lawyer of the Year” and the 2021 Lawyers Weekly Women in Law SME “Partner of the Year”. Naomi is the founder of Pearce IP, which commenced in 2017 and won 2021 “IP Team of the Year” at the Australian Law Awards.
Sian Hope
Lawyer
Sian is a driven intellectual property associate with a background in molecular genetics and experience in both private practice and within State Government. Sian’s experience working in medical research and advanced therapeutics policy supports Pearce IP’s clients on policy issues relating to the regulation of pharmaceutical/biopharmaceutical products in Australia.