Biosimilars

FDA accepts biosimilar filgrastim application

Biosimilars/News | Posted 01/08/2014

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 24 July 2014 that the US Food and Drug Administration (FDA) had accepted its application for approval of the company’s biosimilar filgrastim product.

Biosimilars of darbepoetin alfa

Biosimilars/General | Posted 01/08/2014

Last update: 20 November 2020

Darbepoetin alfa is a synthetic form of erythropoietin. It stimulates erythropoiesis (increases red blood cell levels) and is used to treat anaemia, commonly associated with chronic renal failure and cancer chemotherapy.

Phase I studies of infliximab and rituximab biosimilars demonstrate pharmacokinetic similarity

Biosimilars/Research | Posted 01/08/2014

Results of phase I trials of pharma giant Pfizer’s biosimilar infliximab and rituximab candidates have demonstrated similar pharmacokinetic properties compared to the originator products [1, 2].

32 organizations agree biosimilars should have same names

Biosimilars/General | Posted 04/07/2014

On 1 July 2014, 32 organizations signed a letter calling on the US Food and Drug Administration (FDA) to require biologicals and biosimilars to have the same International Nonproprietary Name (INN).

EMA approves biosimilar insulin

Biosimilars/News | Posted 04/07/2014

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 27 June 2014 that it had recommended granting of marketing authorization for a biosimilar insulin glargine product (LY2963016).

Biosimilar etanercept demonstrates equivalent efficacy

Biosimilars/Research | Posted 04/07/2014

A phase III trial comparing Hanwha Chemical Corporation (Hanwha)’s biosimilar etanercept, HD203, with Enbrel (etanercept) has demonstrated equivalent efficacy [1].

ECCO position statement on biosimilars

Biosimilars/General | Posted 27/06/2014

The European Crohn’s and Colitis Organisation (ECCO) is a non-profit association with the aim of improving the care of patients with inflammatory bowel disease (IBD) in Europe. The association currently includes 2,519 individual experts, 33 country members and 17 corporate members.

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.