Biosimilars approved and marketed in Belgium

2012-06-25 The Federal Agency for Medicines and Health Products (FAMHP), formerly the Directorate-General for Medicinal Products of the Federal Public Service (FPS) Public Health, created in… Read More »

Biosimilars marketed in Europe

2012-06-22 Europe was the first region to approve and introduce biosimilars into the market back in 2006, and now in 2012 the continent is the largest… Read More »

Biosimilar filgrastim provides cost savings for treating febrile neutropenia

2012-06-20 Dr Aapro and co-authors have performed a cost-efficiency analysis for the three most common granulocyte colony-stimulating factors (G-CSF) products used to treat febrile neutropenia: filgrastim… Read More »

Comparison of brand-name and biosimilar etanercept in Korea

2012-06-18 A study comparing pharmacokinetics and tolerability of branded etanercept (25 mg) and its biosimilar (25 mg) in Korea reported by Gu et al has shown… Read More »

Abbott asks FDA to block adalimumab biosimilar

2012-06-15 Abbott Laboratories (Abbott) submitted a 30-page citizen petition to FDA on 2 April 2012 asking the agency to reject any biosimilar for its rheumatoid arthritis… Read More »

EMA reviews its first biosimilar monoclonal antibody

2012-06-13 According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released in April 2012… Read More »

Samsung to launch biosimilars by 2015 at half the current prices

2012-06-11 South Korean electronics giant Samsung told the Financial Times that it plans to launch biosimilars by 2015 at half the prices that patients in Europe and the… Read More »

Removal of barriers for the global development of biosimilars

2012-06-08 At the 2012 Biosimilars Medicines: 10th EGA International Symposium, held in London, UK, on 19–20 April 2012; Mr Nils Behrndt (Deputy Head of Cabinet DG Sanco,… Read More »

Biosimilars dilemma over reference products

2012-06-06 Global manufacturers of biosimilars have a dilemma on their hands concerning reference products. What to do to reduce the burden of data required in different… Read More »

EMA publishes procedural advice for biosimilars

2012-06-04 On 11 April 2012, EMA published a new document on regulatory procedural advice for biosimilars. The guidance brings together a number of regulatory and procedural… Read More »

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