Biosimilars

Phase III QoL assessments show comparability of biosimilar infliximab

The results of phase III quality of life (QoL) assessments of a candidate biosimilar infliximab (CT-P13) have shown the comparability of the biosimilar (CT-P13) and its reference product, Johnson & Johnson’s rheumatoid arthritis blockbuster Remicade (infliximab).

Bioanalytical challenges in the development of biosimilars

Some of the topics presented at an international conference on biowaivers and biosimilars, held in the US in September 2012, were applicable to large-molecule bioanalytical methods. These included assay format, glycosylation and immunogenicity, and how differences in these components can impact the evaluation of biosimilars and their subsequent approval.

Teva launches new biologicals in Europe and US

Teva Pharmaceutical Industries (Teva) announced on 18 November 2013 the first EU launch for its new long-acting filgrastim molecule Lonquex (lipegfilgrastim) in Germany and the launch of its short-acting granulocyte colony-stimulating factor (G‑CSF) Granix (tbo-filgrastim) in the US.

Phase I study shows equivalence of biosimilar rituximab and MabThera

The results of a randomized, controlled, multicentre, two-arm, parallel-group, double-blind study of CT-P10 (rituximab) in patients with rheumatoid arthritis has shown the equivalence, with respect to pharmacokinetics, efficacy and safety, of the biosimilar (CT-P10) and its reference product, Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Germany wants to increase biosimilars penetration

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

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

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

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

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

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’

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

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

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

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

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).

Biosimilars ruling has implications for future patent challenges

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

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

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

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

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

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

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

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].

FDA extends biosimilars deadlines due to US shutdown

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

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

Analysis of carbohydrate containing biosimilars

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

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

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.

Challenges and opportunities for anticancer mAbs

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

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31 July 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.