Biosimilars

Biosimilar infliximab comparable to Remicade

Biosimilars/Research | Posted 27/06/2014

Results from a phase III trial have demonstrated the comparability of US-based Epirus Biopharmaceuticals (Epirus) biosimilar (BOW015) to Remicade for the treatment of rheumatoid arthritis.

Can the pursuit of biosimilar interchangeability go too far?

Biosimilars/Research | Posted 20/06/2014

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.

Darbepoetin alfa ‘similar biologic’ launched in India

Biosimilars/News | Posted 20/06/2014

India-based Hetero, one of the largest manufacturers and suppliers of active pharmaceutical ingredients (APIs) to the Indian pharmaceutical industry, announced on 18 June 2014 the launch of its first ‘similar biologic’ product Actorise, a ‘similar biologic’ of darbepoetin alfa in India.

Biosimilars of etanercept

Biosimilars/General | Posted 20/06/2014

Last update: 20 November 2020

Etanercept is a biological drug that treats autoimmune diseases by inhibiting tumour necrosis factor (TNF); a soluble inflammatory cytokine. Etanercept is indicated for the treatment of rheumatoid arthritis, juvenile idiopathic arthritis and psoriatic arthritis, plaque psoriasis and ankylosing spondylitis.

Biosimilars of epoetin alfa

Biosimilars/General | Posted 13/06/2014

Last update: 4 November 2019

Epoetin alfa is a human erythropoietin produced in cell culture using recombinant DNA technology. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Oncobiologics and IPCA create biosimilars alliance

Biosimilars/News | Posted 13/06/2014

US-based Oncobiologics announced on 2 June 2014 the creation of a two-part alliance for the development, manufacture and commercialization of biosimilar monoclonal antibodies with Indian generics maker IPCA Labs (IPCA).

Top 8 blockbuster biologicals 2013

Biosimilars/General | Posted 06/06/2014

The top three best-selling drugs during 2013 were biologicals. All three best-sellers are indicated for the treatment of arthritis, and include Abbott’s Humira (adalimumab), Merck’s Remicade (infliximab) and Roche’s Rituxan/MabThera (rituximab).

Biosimilars developer Coherus raises US$55 million investment

Biosimilars/News | Posted 06/06/2014

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 19 May 2014 that it had raised investments of US$55 million. New investors KKR & Co LP, Venrock, RA Capital Management, Rock Springs Capital and Fidelity Biosciences joined existing investors Sofinnova Ventures, Lilly Ventures and Vivo Capital.

Biosimilars of bevacizumab

Biosimilars/General | Posted 02/06/2014

Last update: 5 February 2021

Bevacizumab is a humanized monoclonal antibody. It inhibits angiogenesis (the formation of new blood vessels) by blocking the action of vascular endothelial growth factor A (VEGF-A). Bevacizumab can therefore slow the growth of new blood vessels in tumours and is used to treat various cancers, including colorectal, lung, breast, glioblastoma, kidney and ovarian.

ABPI issues updated position paper on biosimilars

Biosimilars/General | Posted 02/06/2014

On 14 May 2014, the association that represents innovative research-based biopharmaceutical companies in the UK, the Association of the British Pharmaceutical Industry (ABPI), issued the third edition of its position paper on biosimilars.

Pfizer to start phase III biosimilar trastuzumab trial

Biosimilars/News | Posted 02/06/2014

Pharma giant Pfizer is to start a global phase III trial for a biosimilar version of trastuzumab.

Biosimilars on the horizon

Biosimilars/General | Posted 23/05/2014

Europe approved its first monoclonal antibody biosimilar, Inflectra/Remsima (infliximab), in September 2013 [1]. But how does the pipeline look for biosimilars and what will be the next biosimilar to be approved?

Merck KGaA to invest Euros 100 million in biosimilars

Biosimilars/News | Posted 23/05/2014

Germany’s Merck KGaA is looking for new sources of growth, one of which it sees as being biosimilars.

Synthon’s SYD985 outperforms Kadcyla in vitro and in vivo

Biosimilars/Research | Posted 23/05/2014

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.

First biogeneric for Iran

Biosimilars/News | Posted 23/05/2014

Iran has developed the country’s first ‘biogeneric’ drug for cancer patients. The announcement was made in the presence of Iran’s Deputy Health Minister Hassan Hashemia at the beginning of February 2014, according to a report in the Tehran Times.

Biosimilar epoetin shows good safety profile in post-authorization study

Biosimilars/Research | Posted 16/05/2014

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].

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.