Biosimilars

Germany wants to increase biosimilars penetration

Biosimilars/General | Posted 13/12/2013

Germany may introduce regulations to increase the uptake of biosimilars in the country, according to Mr Mathias Heck, who serves as the European Union Legal and Policy Counsel with the European Office of the German Pharmaceutical Industry Association (Bundesverband der Pharmazeutischen Industrie, BPI).

Avesthagen and Elpen make deal for biosimilar darbepoetin alfa

Biosimilars/News | Posted 13/12/2013

Indian life science company Avesthagen Pharma (Avesthagen) announced on 19 November 2013 that it had entered into a biosimilars agreement with Greece-based Elpen Pharmaceutical (Elpen).

Norwegian study hopes to increase biosimilars uptake in Europe

Biosimilars/General | Posted 06/12/2013

Despite the fact that many countries within Europe are tightening its health budget, the uptake of lower-cost biosimilars is still relatively low in Europe.

Non-clinical and phase I clinical assessments show similarity of biosimilar rituximab

Biosimilars/Research | Posted 06/12/2013

The results of non-clinical and phase I clinical assessments of a candidate biosimilar rituximab (PF-05280586) have shown similarity, with respect to in vivo, functional characteristics and pharmacokinetic and pharmacodynamic properties, of the biosimilar (PF-05280586) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Copaxone stay rejected and balugrastim withdrawn

Biosimilars/General | Posted 06/12/2013

Teva Pharmaceutical Industries (Teva) had its request for a stay of an appeals court ruling on its blockbuster drug Copaxone (glatiramer acetate) rejected, and that it had withdrawn its application for approval of balugrastim (granulocyte colony-stimulating factor [G-CSF]).

Non-clinical study shows similarity of biosimilar etanercept

Biosimilars/Research | Posted 29/11/2013

The results of a non-clinical study of a candidate biosimilar etanercept (GP2015) has shown the similarity, with respect to in vitro and in vivo characteristics, of the biosimilar (GP2015) and its reference product, Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept).

Indian regulator approves first trastuzumab ‘similar biologic’

Biosimilars/News | Posted 29/11/2013

India’s drug regulator, the Drugs Controller General of India (DCGI), has granted marketing approval for the world first trastuzumab ‘similar biologic’.

Survey highlights the importance of unique names for biosimilars

Biosimilars/General | Posted 29/11/2013

A report released by the Alliance for Safe Biologic Medicines (ASBM) on 22 November 2013 highlights the importance of using unique names for identifying biosimilars.

Merck Serono to transfer technology for six similar biotherapeutic products to Brazil

Biosimilars/News | Posted 29/11/2013

The Brazilian Ministry of Health (Ministério da Saúde) announced on 7 November 2013 a partnership between Brazil’s Bionovis, Fiocruz and Instituto Vital Brazil (IVB) with Germany’s Merck Serono for the production of six ‘similar biotherapeutic products’ for cancer and arthritis.

Biosimilars naming debate intensifies

Biosimilars/General | Posted 22/11/2013

In October 2013, a letter was sent to the US Food and Drug Administration (FDA) by a bipartisan group of US senators calling for biosimilars to have the same active ingredient name as the brand-name originator product [1]. This has prompted a response from ‘authors and champions’ of the biosimilars legislation.

Sharing biosimilars substitution information with patients critical

Biosimilars/Research | Posted 22/11/2013

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

Biosimilars/Research | Posted 22/11/2013

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).

Biosimilars ruling has implications for future patent challenges

Biosimilars/News | Posted 15/11/2013

Biosimilars manufacturers may not be able to make early challenges on biologicals patents according to a ruling which rejected Sandoz’s request to invalidate patents for Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). This appears to be the first court decision interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCI Act).

Etanercept biosimilar has comparable pharmacokinetics to Enbrel

Biosimilars/Research | Posted 15/11/2013

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

Similar biotherapeutic products under development in Latin America

Biosimilars/General | Posted 15/11/2013

Last update: 15 November 2013

Similar biotherapeutic products are high on the health policy agenda in Latin America, due to the fact that they are less costly and therefore have the potential to increase access to life-saving drugs. Within individual Latin American countries, the regulatory processes and stages of implementation of similar biotherapeutic products regulation vary widely. Despite this, Latin America is moving towards increasing standards of regulation for these products [1, 2].

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

Biosimilars/Research | Posted 08/11/2013

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.

Stada in-licenses biosimilar filgrastim

Biosimilars/News | Posted 08/11/2013

German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from Canada-based Apotex.

EGA commends EMA workshop on biosimilars guidelines

Biosimilars/General | Posted 08/11/2013

The European Generic medicines Association (EGA) has congratulated the European Medicines Agency (EMA) on its organization of the EMA workshop on biosimilars and urges rapid adoption of its revisions to the agency’s overarching guidelines on biosimilars.

Calls for biosimilars to have same INN at WHO meeting

Biosimilars/General | Posted 31/10/2013

Last update: 7 February 2014

The World Health Organization (WHO) held its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances on 22 October 2013 in Geneva, Switzerland. During the meeting some stakeholders called for biosimilars to be assigned the same INN as their reference biologicals, while others called for the use of distinct non-propriety names.

Clinical trials for follow-on biological products in Brazil

Biosimilars/Research | Posted 31/10/2013

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].