Biosimilars
Adalimumab biosimilar meets primary endpoints in phase I study
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
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 proposed biological qualifier (BQ) for naming biologicals were positive.
Promoting generics prescribing in the US
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].
Samsung adds 48-week extension to SB4 biosimilar study
Samsung Bioepis has added a 48-week extension to the phase III study of its candidate etanercept biosimilar SB4 in rheumatoid arthritis patients.
Generics group established first voice for biosimilars in Canada
The Canadian Generic Pharmaceutical Association (CGPA), which represents Canada’s generics industry, announced on 7 April 2015 that it had set up a new CGPA Biosimilars Board, with Mr Michel Robidoux, President and General Manager of Sandoz Canada, as its inaugural Chair.
Arguments for same INN for biosimilars presented at WHO meeting
The World Health Organization recently held its 60th Consultation on International Nonproprietary Names (INN) for Pharmaceutical Substances. At the meeting the issue of naming of biologicals, including biosimilars was once again discussed.
Substitution of biosimilars in the US
The approval of the first biosimilar in the US, Zarxio (filgrastim), on 6 March 2015 [1], prompted Sarpatwari and co-authors to investigate how biosimilars might be substituted for originator biologicals in the US [2].
Merck outlines biosimilars programme
During the 35th Annual Health Care Conference held on 2−4 March 2015 in Boston, USA, US pharma giant Merck outlined its biosimilars programme.
Dutch medicines agency says biosimilars ‘have no relevant differences’ to originators
The Dutch Medicines Evaluation Board (MEB) has updated its position on biosimilars, stating that ‘biosimilars have been proven to have no relevant differences compared to an innovator biological medicinal product as far as quality, safety and efficacy are concerned’.
Substitution of generics in the US
In order to evaluate how strategies to promote the prescribing of generics by physicians in the US might apply to biosimilars, Sarpatwari and co-authors discuss the types of substitution possible with generics [1].
