Biosimilars
Rituximab ‘similar biologic’ shows equivalent efficacy and safety
A retrospective analysis of cancer patients who received either originator or ‘similar biologic’ rituximab chemotherapy showed comparable efficacy and safety [1].
Biosimilars approved in New Zealand
Last update: 2 May 2014
In New Zealand, the regulatory body for the approval of medicines, including biosimilars, is the New Zealand Medicines and Medical Devices Safety Authority (Medsafe).
Challenges for the regulation of biosimilars
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
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’
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
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
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
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
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
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].
