Biosimilars
Canada approves three more biosimilars in 2022
Since the last update in June 2022, Health Canada has approved three more biosimilars (Myxredlin, Rymti, Elonox) in 2022 [1].
EMA recommends approval of bevacizumab Lytenava
On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorization (MA) for Outlook Therapeutics’ Lytenava (ONS-5010, bevacizumab gamma), intended for treatment of neovascular (wet) age-related macular degeneration (nAMD).
Three more biosimilar approvals in Canada in 2023
In Canada, three biosimilars were approved in late 2023. These are, Amgen’s Wezlana (ustekinumab), JAMP/Alvotech’s Jamteki (ustekinumab), and Formycon/Polpharma Biologics/Bioeq’s Ranopto (ranibizumab).
EMA recommends approval of first omalizumab biosimilar Omlyclo
On 21 March 2024, the European Medicines Agency's (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of marketing authorization for Omlyclo (omalizumab), Celltrion's biosimilar of the reference product Xolair.
Unveiling key clinical findings for denosumab biosimilar candidates
In April 2024, Henlius Biotech and Organon announced that the phase III comparative clinical trial for their investigational denosumab biosimilar (HLX14) met the primary endpoints. This follows the news released earlier in the year, that Alvotech and Polpharma achieved positive topline results from their pharmacokinetic (PK) studies for their denosumab biosimilar candidate (AVT03). The originator product is Amgen’s Prolia/Xgeva.
China approves first denosumab copy biological Maiweijian
On 3 April 2024, China-based biopharmaceutical company Mabwell announced that their Maiweijian (denosumab) injection, developed by its wholly-owned subsidiary T-mab, obtained the marketing approval from China’s National Medical Products Administration (NMPA). This product is the first denosumab copy biologicalto receive marketing approval in China.
Addressing the persistent gap in Medicare access to Humira biosimilars
In an article by Dr Joshua Cohen, he discusses the challenges facing the adoption of biosimilars in the US, particularly focusing on Medicare beneficiaries' access to these lower-cost alternatives to brand-name biologicals like Humira.
Topline results for Polpharma Biologics’ vedolizumab biosimilar candidate
In February 2024, Polpharma Biologics (Polpharma) unveiled topline results demonstrating the pharmacokinetic (PK) and pharmacodynamic (PD) comparability of PB016, their biosimilar candidate for vedolizumab, with its reference drug, Entyvio, by Takeda Pharmaceutical.
EMA recommends approval of first denosumab biosimilar Jubbonti and Wyost
On 21 March 2024, the European Medicines Agency’s (EMA) Committee for Medicinal Products for Human Use (CHMP) adopted a positive opinion, recommending the granting of a marketing authorisation for Sandoz’s medicinal products, Jubbonti and Wyost (denosumab), which are biosimilars of Amgen’s reference products Prolia and Xgeva, respectively.
First denosumab biosimilars approved in Canada and the US
The first and only denosumab biosimilars for osteoporosis and increasing bone mass were approved in Canada and the US in February and March 2024.
