The Committee for Human Medicinal Products (CHMP) has recommended the approval of new eight medicines. A positive opinion of a marketing authorisation was granted for Altuvoct (efanesoctocog alfa), as a treatment and prophylaxis of bleeding in patients with the rare blood disorder haemophilia A. Last week, the US FDA approved a new gene therapy for eligible adults with haemophilia B. Recommendations for new cancer treatments The committee also adopted a positive opinion for Fruzaqla (fruquintinib) for previously treated metastatic colorectal cancer in adults. If approved, fruquintinib could p ..read more

“approval [of Pyzchiva® (biosimilar ustekinumab)] of is a crucial step towards offering European patients an additional safe and effective treatment option” Pharmaceutical company Sandoz has announced that the European Commission (EC) has granted marketing authorisation for Pyzchiva® (biosimilar ustekinumab). Pyzchiva was developed and registered by Samsung Bioepis to match the reference medicine. It is approved for autoimmune disorders within disease areas such as gastroenterology and dermatology. “This approval is a crucial step towards offering European patients an additio ..read more

A new global licensing agreement is set to advance development of an oncology biosimilar candidate. Teva Pharmaceuticals International GmbH, a subsidiary of Teva Pharmaceutical Industries Ltd. and Spain-based biopharmaceutical company mAbxience, have entered into a strategic deal for a drug candidate that is in development for treating multiple indications in the oncology space. Initiation of the licensing agreement will help Teva to grow its biosimilar pipeline. mAbxience will be able to further its global expansion strategy. The deal covers several drug markets worldwide, including in Europ ..read more

Expirations of biologic patents has enabled manufacturers to enter the market and offer lower-cost alternatives of these drugs, [which has] resulted in increased competition and price pressure, driving the growth of the biosimilar market” A report published by Towards Healthcare has estimated that the global biosimilar market will value $1,26,019.67 million by 2032, at 17.6 percent CAGR between 2023 and 2032. Key drivers for the market include patent expirations of several biologic drugs and increasing demand for affordable biologic treatments, the author explained. Over the past few years ..read more

The US Food and Drug Administration (FDA) has approved the first and only FDA-approved denosumab biosimilars, to treat all indications of the reference medicines. This means that Sandoz’s Wyost® (denosumab-bbdz) and Jubbonti® (denosumab-bbdz) are interchangeable for all indications of reference medicines Xgeva® (denosumab) and Prolia® (denosumab). Keren Haruvi, President Sandoz North America highlighted that denosumab is a medicine that can address primary and secondary bone loss, such as osteoporosis, as well as cancer-related skeletal events. As US-approved biosimilars, Wyost and Jubbo ..read more

The European Commission (EC) has granted a marketing authorisation for Uzpruvo® (AVT04) in Europe, a biosimilar candidate to Stelara® (ustekinumab). Ustekinumab biologic Once the European Supplementary Protection Certificate (SPC) for Stelara expires in July 2024, this will open up market entry as soon as possible for Uzpruvo, now that it is approved in Europe” Ustekinumab is a human IgG1κ monoclonal antibody (mAb). Uzpruvo is produced in Sp2/0 cells via perfusion, in the same way that the reference product Stelara is. The biologic targets the p40 protein, which has key roles ..read more

In Q1 2023, the European Commission (EC) announced proposed changes to EU pharmaceutical legislation.1 The changes form part of the 2020 Pharmaceutical Strategy for Europe will impact pharma and biopharma companies operating in Europe.  The proposed changes to EU pharmaceutical legislation broadly aim to: Support innovation and boost attractiveness of EU market Ensure timely and equitable access to medicines for patients across the EU Address other ongoing issues, including antimicrobial resistance and environmental impact of medicines. These proposed changes can be categorised into se ..read more

While Europe has historically been a pioneer in the adoption of biosimilars, a new report by the global initiative Act4Biosimilars has revealed differences country by country, including disparities between Eastern and Western Europe. This is based on research from a report published in April this year by IQVIA. [Act4Biosimilars’ Regional Deep Dive Report Europe] noted that biosimilar adoption levels vary significantly across Europe” Act4Biosimilars shared that their Deep Dive Report for Europe “encourages local stakeholders to use the Act4Biosimilars Action Plan to establish the s ..read more

Issue 5 of European Pharmaceutical Review features articles on manufacturing, development and quality control of biopharmaceuticals from antibodies to mRNA and cell and gene therapies.  In this issue, Peter Stenico, Biosimilar Global Platform Head at Sandoz, highlights how emerging technology platforms such as nanobodies, ADCs and cell and gene therapies are “on course to revolutionise medicine,” with significant growth anticipated over the next decade. Stenico looks at the potential expansion of biosimilars in Europe, explaining how creating a sustainable procurement process, that ..read more

The US Food and Drug Administration (FDA) has approved Wezlana (ustekinumab-auub) as a biosimilar to Johnson & Johnson’s Stelara (ustekinumab). Wezlana, like Stelara, is approved to treat: Adults and children six years and older with moderate to severe plaque psoriasis who are candidates for phototherapy or systemic therapy; Patients six years and older with active psoriatic arthritis Adults with moderately to severely active Crohn’s disease Adults with moderately to severely active ulcerative colitis. The FDA said its approval of Wezlana is based on “a comprehensive review of scientifi ..read more