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Can the pursuit of biosimilar interchangeability go too far?

The question of biosimilar interchangeability – whether or not a biosimilar can safely be switched with another biosimilar or with the originator product – is a thorny one. In fact, write Hans C Ebbers and Paul Chamberlain [1], striving for some of the standards suggested to certify interchangeability may not be in a patient’s best interests.

Synthon’s SYD985 outperforms Kadcyla in vitro and in vivo

Synthon announced on 2 April 2014 that its antibody-drug conjugate SYD985 had outperformed Roche’s breast cancer blockbuster Kadcyla (trastuzumab emtansine) in a head-to-head comparison.

Biosimilar epoetin shows good safety profile in post-authorization study

US-based generics manufacturer Hospira announced on 28 April 2014 positive results from a post-authorization observational safety study of its biosimilar epoetin product Retacrit/Silapo (epoetin zeta) in patients with renal anaemia [1].

Biosimilar trastuzumab candidates in phase III development

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.

Biosimilars for inflammatory bowel disease in Norway

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].

Biosimilar G-CSF safe for mobilization of stem cells

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].

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].

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].

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].

Cost savings to be made by switching to Zarzio

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].

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