Biosimilars

Biosimilars applications under review by EMA – April 2014

Biosimilars/General | Posted 16/05/2014

The European Medicines Agency (EMA) is the body responsible for approval of biosimilars within the European Union (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.

Celltrion files infliximab patent lawsuit in US

Biosimilars/News | Posted 16/05/2014

South Korean biotechnology company Celltrion filed a lawsuit on 31 March 2014 in a federal court in Massachusetts seeking a declaratory judgement that Janssen Biotech’s (Janssen) remaining patents on the reference drug Remicade (infliximab) are invalid and unenforceable.

Biosimilars for inflammatory bowel disease in Norway

Biosimilars/Research | Posted 09/05/2014

Europe approved its first biosimilar monoclonal antibody Inflectra/Remsima (infliximab) on 10 September 2013 [1]. The biosimilar is now recommended by the Norwegian Drug Procurement Cooperation (LIS) as the first choice, which carries out the procurement for all medicines financed by public hospitals in Norway. Gastroenterologists, however, are cautious about using the biosimilar ‘until more studies of the new medicine have been completed’ [2].

Sandoz advances biosimilars pipeline

Biosimilars/News | Posted 09/05/2014

Sandoz, the generics unit of Swiss pharma giant Novartis, announced on 28 April 2014 that it had reached several important milestones in the development of biosimilar etanercept, filgrastim and pegfilgrastim.

Biosimilar trastuzumab candidates in phase III development

Biosimilars/Research | Posted 09/05/2014

The introduction of Herceptin (trastuzumab) revolutionalized the treatment of breast cancer. Prior to its introduction there were few treatment options available to women with human epidermal growth factor receptor 2-positive (HER2+) breast cancer.

Biosimilar merger for Epirus and collaboration for Catalent

Biosimilars/News | Posted 09/05/2014

Mergers and collaborations are still in vogue in the biosimilars arena. The latest firms to announce deals are Epirus Biopharmaceuticals (Epirus), which will merge with Zalicus; and Catalent, which has agreed to a biosimilar development collaboration with Zhejiang Hisun Pharma.

Biosimilar G-CSF safe for mobilization of stem cells

Biosimilars/Research | Posted 02/05/2014

A study into the use of granulocyte colony-stimulating factor (G-CSF) biosimilars for peripheral blood haematopoietic stem cell (PBSC) mobilization has found them to be equivalent to the reference G-CSF [1].

Lupin and Yoshindo start biosimilars joint venture

Biosimilars/News | Posted 02/05/2014

Indian generics’ manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 April 2014 that the company had entered into a joint venture with Japanese generics maker Yoshindo for a biosimilars joint venture in Japan.

Rituximab ‘similar biologic’ shows equivalent efficacy and safety

Biosimilars/Research | Posted 02/05/2014

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

Biosimilars/General | Posted 02/05/2014

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

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].