Biosimilars

Challenges for the regulation of biosimilars

Biosimilars/Research | Posted 25/04/2014

The European Medicines Agency (EMA) was the first agency to issue guidelines for the approval of biosimilars via an abbreviated registration process back in 2006. Since then the agency has developed many general and specific guidelines for biosimilars, as well as approved 18 biosimilars to date [1]. Tsiftsoglou and co-authors, however, believe that many challenges still lie ahead for this class of biologicals, some of which are discussed here [2].

Rituximab non-originator biological approved in Russia

Biosimilars/News | Posted 25/04/2014

Russian biotechnology company Biocad announced on 17 April 2014 that the Russian Ministry of Health has approved the company’s rituximab non-originator biological, AcellBia (BCD-020). The drug is a non-originator biological of Roche’s rheumatoid arthritis blockbuster MabThera/Rituxan (rituximab).

Brazil’s ANVISA approves Cristália for production of ‘follow-on biological products’

Biosimilars/News | Posted 25/04/2014

Brazilian drugmaker Cristália has taken a step closer to its goal of producing ‘follow-on biological products’ domestically after receiving clearance from the country’s drug regulator, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).

Regulatory principles for biosimilar monoclonal antibodies

Biosimilars/Research | Posted 18/04/2014

It is sometimes argued that there is less clinical evidence for biosimilars. However, Tsiftsoglou and co-authors pointed out that European Medicines Agency (EMA) guidelines for biosimilars are not primarily driven by feasibility considerations or to make it as easy as possible, but to add to the totality of evidence. And it is this that finally drives the regulatory acceptance of a biosimilar [1].

Biosimilars knowledge gap needs addressing

Biosimilars/General | Posted 18/04/2014

The European Generic medicines Association (EGA) has called upon national authorities and medical societies to actively engage in reducing the knowledge gap about biosimilars.

Long-term safety study of biosimilar anti-TNF initiated

Biosimilars/News | Posted 18/04/2014

The Polish Society of Gastroenterology is starting an observational trial to study the long-term safety of anti-tumour necrosis factor (TNF) antibodies, including biosimilars, in the treatment of inflammatory bowel disease (IBD), according to ClinicalTrials.gov.

WHO investigates use of a biological qualifier for biosimilars

Biosimilars/General | Posted 11/04/2014

The World Health Organization is still discussing several different options on how to name biosimilars, according to the recently published executive summary of its 57th Consultation on International Nonproprietary Names (INNs) for Pharmaceutical Substances.

Quality by design for biosimilars

Biosimilars/Research | Posted 11/04/2014

A study into the use of quality by design (QbD) has demonstrated how risk management can facilitate the implementation of QbD in the early-stage product development of biosimilars [1].

Celltrion starts phase III biosimilar trastuzumab trial

Biosimilars/News | Posted 11/04/2014

South Korean biotechnology company Celltrion is starting a phase III clinical trial for its biosimilar trastuzumab candidate (CT-P6) in patients with human epidermal growth factor receptor 2-positive (HER2+) early breast cancer, according to the European Union’s Clinical Trials Register.

Cost savings to be made by switching to Zarzio

Biosimilars/Research | Posted 04/04/2014

Since the first filgrastim biosimilar was approved in 2008, there is now five years of data on which to assess the efficacy, safety and cost-effectiveness of biosimilar granulocyte colony-stimulating factors (G-CSFs). A pooled analysis of post-approval studies of one of the most common biosimilar G-CSFs, Zarzio (filgrastim), is presented by Pere Gascón and co-authors [1]. Their findings highlight significant cost savings in health authority regions that have switched from the originator G-CSF to its biosimilar Zarzio. The study overturns early concerns that cost savings would not be so great as hoped [2].