Biosimilars

FDA extends biosimilars deadlines due to US shutdown

Biosimilars/General | Posted 31/10/2013

As a result of the US government shutdown, the US Food and Drug Administration (FDA) has extended the deadlines and goal dates for its biosimilars activities.

Biocad and Epirus to invest in follow-on biological products in Brazil

Biosimilars/News | Posted 31/10/2013

Biocad Russia is to open a US$40 million facility to produce three follow-on biological products in Brazil.

Analysis of carbohydrate containing biosimilars

Biosimilars/Research | Posted 31/10/2013

During a presentation given by Dr Azadi Parastoo, University of Georgia, GA, USA, at the international conference on biowaivers and biosimilars, held in the US in September 2012, the types of analytical techniques that can be utilized in order to characterize differences in glycosylation for analysis of biosimilars were discussed [1].

WHO naming of biosimilars

Biosimilars/General | Posted 25/10/2013

The World Health Organization (WHO) has proposed a system of naming for biosimilars, which has been commended by some groups [1], but criticized by others.

Extrapolation of biosimilar infliximab indications to inflammatory bowel disease

Biosimilars/Research | Posted 25/10/2013

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

Biosimilars/General | Posted 25/10/2013

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

Biosimilars/General | Posted 25/10/2013

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

Biosimilars/Research | Posted 18/10/2013

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

Biosimilars/Research | Posted 11/10/2013

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

Biosimilars/Research | Posted 04/10/2013

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

Biosimilars/General | Posted 04/10/2013

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

Biosimilars/General | Posted 27/09/2013

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/Research | Posted 27/09/2013

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

Biosimilars/News | Posted 27/09/2013

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.

Challenges and opportunities for anticancer mAbs

Biosimilars/Research | Posted 20/09/2013

Several best-selling monocloncal antibodies (mAbs) are due to lose patent protection; presenting regulatory authorities with a complex set of challenges as they prepare for the arrival of novel biosimilars, note Ebbers and co-authors at Utrecht University, The Netherlands [1].

EMA approves biosimilar follitropin alfa and somatropin

Biosimilars/News | Posted 20/09/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31July 2013 that it had recommended granting of marketing authorization for a biosimilar follitropin alfa. While on 9 September 2013, the agency announced the approval of a new somatropin biosimilar.