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Sharing biosimilars substitution information with patients critical

On 12 October 2013, California Governor Jerry Brown vetoed legislation known as SB 598. Some believed this bill would have impeded access to biosimilars, but others believe it would have supported and strengthened patient-provider communication [1].

Open-label studies show similarity of biosimilar infliximab and Remicade

The results of two open-label extension studies of Inflectra (CT-P13; infliximab), one in patients with rheumatoid arthritis, the other in patients with ankylosing spondylitis, have confirmed the similarity, with respect to efficacy and safety, of the biosimilar infliximab and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Etanercept biosimilar has comparable pharmacokinetics to Enbrel

An etanercept biosimilar (CHS-0214) from fledgling biotech company Coherus Biosciences (Coherus) has shown comparable pharmacokinetics in a pivotal clinical study.

Use of similar biotherapeutic products to treat rheumatoid arthritis in Latin America

Latin America has a significantly lower gross domestic product (GDP) compared to Canada, Europe and the US. Despite this fact, the cost of biologicals is in general very similar to countries with higher GDP, causing problems for patients to gain access to these medications. This problem could possibly be solved by the introduction of lower-cost biosimilars to the region.

Clinical trials for follow-on biological products in Brazil

Unlike for generic drugs, authorizing biosimilars without conducting quality clinical trials represents a real threat to patients, according to Professor Valderílio Feijó Azevedo, Professor of Rheumatology at the Universidade Federal do Paraná in Brazil [1].

Extrapolation of biosimilar infliximab indications to inflammatory bowel disease

Gastroenterologists are wary of using biosimilars of infliximab in the treatment of inflammatory bowel disease. This fact is being evidenced by the publication of position statements from various professional groups.

The future of nanomedicines – nanosimilars

First there were generics, then came biosimilars and soon the European Medicines Agency (EMA) is anticipating the first nanosimilars, or similar versions of originator nanomedicines.

More immunogenicity data needed for biosimilar mAbs

Eight therapeutic monoclonal antibodies (mAbs) will lose EU and US patent protection before 2020, making way for a new class of biosimilar. The promise of biosimilar mAbs is enticing, but these are more complex molecules than current biosimilars and it is unclear how their similarity with originator mAbs will be tested.

The future of biosimilar mAbs in Europe

Biosimilars – products that are similar to originator biological medicinal products – have had a positive impact on healthcare systems. But it takes up to four years following market approval before biosimilars are accepted by the clinical community and by the people holding the purse strings. Now, a new class of biosimilar –monoclonal antibodies (mAbs) – is set to challenge the system further, writes Professor Andrea Laslop of the Austrian Agency for Health and Food Safety [1].

Regulation of similar biotherapeutic products in Latin America

Regulation of similar biotherapeutic products (SBPs) in Latin America varies widely among different countries and, although many countries have yet to introduce guidance for biosimilars, the region is moving towards increasing standards of regulation for these products [1, 2].