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FDA approves first generics of antipsychotic drug Generics/News | Posted 04/05/2015

The US Food and Drug Administration (FDA) announced on 28 April 2015 the approval of the first generics of Otsuka Pharmaceutical’s schizophrenia drug Abilify (aripiprazole).

Australian guide to biosimilars Biosimilars/General | Posted 04/05/2015

Australia’s Generic Medicines Industry Association (GMiA) has launched a Guide to Biosimilars. The guide is designed to provide a concise, ‘user-friendly’ reference on the subject for patients, cli...

Adalimumab biosimilar meets primary endpoints in phase I study Biosimilars/Research | Posted 04/05/2015

US biotech company Oncobiologics announced on 12 February 2015 that ONS-3010, its adalimumab biosimilar candidate, met the primary endpoints in its first clinical study.

WHO receives positive feedback on BQ for biologicals Biosimilars/General | Posted 27/04/2015

According to the World Health Organization’s executive summary of its 59th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances, almost half of comments on its pr...

Promoting generics prescribing in the US Biosimilars/Research | Posted 27/04/2015

Sarpatwari and co-authors discuss physician-centered strategies used to promote generics prescribing in the US and how such strategies might apply to biosimilars [1].

US health insurance CMS outlines biosimilar policy Policies & Legislation | Posted 27/04/2015

The Centers for Medicare & Medicaid Services (CMS), which provides health insurance for the elderly and children in the US, has issued three biosimilar reimbursement documents. The documents co...

Poland’s experience with generic imatinib Generics/Research | Posted 27/04/2015

In July 2014, Poland became the first country in the European Union (EU) to introduce a generic form of the chronic myeloid leukaemia (CML) treatment imatinib. This, and the dearth of reliable info...

Samsung adds 48-week extension to SB4 biosimilar study Biosimilars/News | Posted 27/04/2015

Samsung Bioepis has added a 48-week extension to the phase III study of its candidate etanercept biosimilar SB4 in rheumatoid arthritis patients.