CHMP meeting highlights: April 2024
In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
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In its April meeting, the EMA’s human medicines committee recommended eight new medicines, including treatments for cancer and autoimmune diseases.
The agreement between Teva and mAbxience for the oncology biosimilar candidate will help to reduce costs within healthcare.
Cost effectivity of biosimilars is predicted to be a key contributor to growth of the global biosimilar market to 2032, research states.
At the Committee for Medicinal Products for Human Use (CHMP)’s March meeting, twelve medicines received positive opinions for marketing authorisations, including a new antibiotic and a novel oral medicine for a rare blood disorder.
The approval authorises the interchangeability of denosumab biosimilars in the US to treat primary and secondary bone loss.
Ten new medicines, including a new oligonucleotide therapy for ALS, were recommended for approval at the Committee for Medicinal Products for Human Use (CHMP)’s recent meeting.
To ensure timely market entry of generics and biosimilars in the EU, the Supplementary Protection Certificate (SPC) Manufacturing Waiver must be clearer, asserts Medicines for Europe.
Following the acquisition from Viatris, Biocon Biologics and its partners state that they will commercialise biosimilar products in 31 European countries.
A new report reveals that low biosimilar adoption in certain European regions is impacting biologic medicine access for patients.
Alongside its new biosimilar facility, Sandoz’s new penicillin production process will help secure European-based antibiotic supply.
As a newly independent company, Sandoz will concentrate on developing generic and biosimilar medicines, while its former parent company Novartis plans to drive its business forward with a strategic focus on innovative medicines.
Sandoz’s Tyruko (natalizumab-sztn) is now the first US Food and Drug Administration (FDA)-approved biosimilar to Tysabri (natalizumab) injection for relapsing forms of multiple sclerosis.
A planned investment of approximately $90 million will help build Sandoz’s new Slovenia-based biopharma biosimilar development facility by 2026.
Samsung Biologics has signed two long-term manufacturing agreements for Pfizer’s multiproduct biosimilar portfolio, worth $897 million.
A marketing authorisation for a biosimilar to eculizumab has been granted by the European Commission for paroxysmal nocturnal haemoglobinuria.