The European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) recently adopted positive opinions for three biosimilar products. On June 23, 2022, CHMP recommended the grant of a marketing authorization for RANIVISIO (ranibizumab) to Midas Pharma GmbH. RANIVISIO references LUCENTIS® and, if approved, would be used to…
Celltrion recently announced that it will start selling Yuflyma, an adalimumab biosimilar, in the U.S. in July 2023. The announcement stems from Celltrion’s recently inked patent agreement with AbbVie which allows Celltrion to market a high-concentration formulation of the drug. As a company official stated, “By entering the U.S. market…
On March 30, 2022, Fresenius Kabi announced that the European Commission approved STIMUFEND, a pegfilgrastim biosimilar referencing NEULASTA, for patients with non-myeloid cancer who are receiving myelosuppressive chemotherapy. STIMUFEND, to launch in a prefilled syringe, is Fresenius’s first approved molecule in its oncology biosimilar portfolio and second biosimilar approved in…
On March 15, 2022, the Patent Trial and Appeal Board (PTAB) denied institution of post-grant review (PGR) proceedings initiated by Celltrion Inc. concerning Regeneron Pharmaceutical’s U.S. Patent No. 10,857,231 (the ’231 Patent) after Regeneron disclaimed the patent. The ’231 patent has claims directed to formulations of aflibercept, the active ingredient…
On March 24, 2022, Celltrion Healthcare announced that it had won a bid to the Brazilian Federal Government to supply a biosimilar version of Remsima® (infliximab), along with bids to 12 Brazilian states. According to the company, infliximab will be the third biosmilar product that Celltrion is to supply to…
According to various reports, Celltrion has received approval from Health Canada for YUFLYMA, a biosimilar of AbbVie’s HUMIRA product. YUFLYMA was previously approved in Europe, and is a high-concentration, low-volume, citrate-free formulation of adalimumab.
The Korea Herald has reported that Celltrion Inc., a South Korean biopharmaceutical firm, is seeking approval from the European Medicines Agency (EMA) for the sale of CT-P16, Celltrion’s anticancer biosimilar candidate. CT-P16 references Avastin (Bevacizumab), which is indicated for the treatment of various types of cancers, including colorectal, lung, and kidney…
Celltrion Healthcare announced last week that it received positive results from the Phase III trial of its high-concentration, low-volume, citrate-free adalimumab biosimilar, CT-P17 or Yuflyma™, in patients with active rheumatoid arthritis (RA). According to the press release, “[r]esults demonstrated comparable efficacy in terms of ACR20/50/70 response rates, both in patients…
On March 29, Samsung Bioepis announced the launch of its adalimumab biosimilar HadlimaTM, referencing AbbVie’s HumiraTM, in Australia in partnership with Merck & Co. HadlimaTM is approved for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis, psoriatic arthritis, ankylosing spondylitis, adult and paediatric Crohn’s disease, ulcerative colitis, hidradenitis suppurativa and…
On February 15, 2021, Celltrion Healthcare announced that the European Commission granted marketing authorization for Yuflyma™ (CT-P17), an adalimumab biosimilar, on February 11, 2021. Yuflyma™ was approved across all thirteen intended indications covered by the reference biologic, Humira®. Yuflyma™ is a high concentration, low-volume and citrate-free adalimumab biosimilar, which, according…