Biosimilars
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.
Similar biotherapeutic products approved and marketed in Latin America
Last update: 29 November 2019
Regulation of similar biotherapeutic products in Latin America varies widely among different countries. Although many countries have yet to introduce guidance for biosimilars, Latin America is moving towards increasing standards of regulation for these products [1, 2].
EGA’s vision for biosimilars and generics
On 8 October 2013, the European Generic medicines Association (EGA) launched its industrial policy vision for the future of the biosimilars and generics industries in Europe at the EGA Industrial Policy Conference.
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.
Establishing mAb biosimilarity before reaching the clinic
Confirming the biosimilarity of monoclonal antibodies (mAbs) is fraught with challenges beyond those faced by currently approved biosimilars, warn Ebbers and co-authors at Utrecht University, The Netherlands [1]. The threat of unexpected immunogenicity has been well reported, but the problems do not start there. The first steps towards establishing the biosimilarity of an anticancer mAb, the preclinical stage, presents challenges of its own.
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.
Biosimilars applications under review by EMA – 2013 Q3
Last update: 4 October 2013
The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the EU. A legal framework for approving biosimilars was established in 2003. Approval of biosimilars is based on an abbreviated registration process, which allows biosimilars manufacturers to provide a reduced package of information compared to originator drugs, provided they can prove ‘similarity’ to the originator or reference drug.
Fight continues over biosimilar naming standards
Biosimilar products marketed in the US should share the same common non-proprietary name as the reference brand-name biological medicine, according to the Generic Pharmaceutical Association (GPhA).
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].
Amgen to start phase III trial for biosimilar adalimumab
Biotechnology giant Amgen is to start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe rheumatoid arthritis according to the EU Clinical Trials Register.
