Biosimilars/News

Epirus and Ranbaxy sign agreement for infliximab 'similar biologic'

Biosimilars/News | Posted 07/02/2014

Epirus Switzerland, a subsidiary of US-based Epirus Biopharmaceuticals, and India-based Ranbaxy Laboratories (Ranbaxy) announced on 9 January 2013 that the two companies had signed a licensing agreement for BOW015, an infliximab biosimilar.

FDA accepts applications for three-times-weekly follow-on Copaxone

Biosimilars/News | Posted 05/09/2014

The US Food and Drug Administration (FDA) has accepted applications submitted by generics makers Dr Reddy’s, Sandoz (Momenta Pharmaceuticals’ development and commercialization partner), and Mylan for three-times-weekly follow-on versions of blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Coherus starts phase III biosimilar etanercept trial

Biosimilars/News | Posted 14/08/2014

US-based biosimilars developer Coherus BioSciences (Coherus) announced on 23 June 2014 the start of a global phase III trial for a biosimilar version of etanercept.

Biosimilar infliximab receives approval in Japan and Turkey

Biosimilars/News | Posted 08/08/2014

South Korean biotechnology company Celltrion announced on 4 and 16 July 2014 that the company had received marketing approval for its biosimilar Remsima (infliximab) in Japan and Turkey, respectively.

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.

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).

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).

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.

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.

Alvotech and Finesse enter into biosimilars collaboration

Biosimilars/News | Posted 04/04/2014

Iceland-based biopharmaceutical company Alvotech and US-based bio-process management company Finesse Solutions (Finesse) announced on 14 March 2014 that they had entered into a partnership for bio-manufacturing.

Biosimilar filgrastim gains Japanese approval

Biosimilars/News | Posted 28/03/2014

Sandoz (the generics unit of Novartis) announced on 24 March 2014 that its subsidiary Sandoz Japan had received marketing authorization approval for its biosimilar filgrastim (Filgrastim BS Sandoz).

Long-acting G-CSF lipegfilgrastim launched in UK

Biosimilars/News | Posted 21/03/2014

Teva UK, a subsidiary of generics giant Teva Pharmaceutical Industries (Teva) announced on 24 February 2014 the launch of its long-acting granulocyte colony-stimulating factor (G‑CSF) Lonquex (lipegfilgrastim) in the UK.

Amgen starts another phase III trial for biosimilar adalimumab

Biosimilars/News | Posted 14/03/2014

US biotechnology giant Amgen has started recruiting for a phase III clinical trial of its biosimilar adalimumab in patients suffering from plaque psoriasis, according to the US clinical trials website, Clinicaltrials.gov.

Kissei makes biosimilars deal with Alteogen

Biosimilars/News | Posted 07/03/2014

Japan-based Kissei Pharmaceutical (Kissei) announced on 13 February 2014 that the company had entered into a collaboration agreement with South Korean biologicals company Alteogen.

Biocon and Mylan challenge Indian ban on trastuzumab ‘similar biologics’

Biosimilars/News | Posted 28/02/2014

India-based biologicals specialist Biocon and US generics maker Mylan have challenged the Delhi High Court’s interim order that barred them from using Switzerland-based drug giant Roche’s data to sell their ‘similar biologic’ versions of Roche’s breast cancer blockbuster Herceptin (trastuzumab).

Merck and Samsung Bioepis collaborate on biosimilar insulin

Biosimilars/News | Posted 28/02/2014

US pharma giant Merck and Korean electronics giant Samsung’s specialized biologicals unit, Samsung Bioepis, announced on 10 February 2014 that they had expanded their collaboration with an agreement to develop, manufacture and commercialize MK-1293, a biosimilar insulin glargine candidate for the treatment of patients with type 1 and type 2 diabetes.

Alvogen launches infliximab biosimilar in Europe

Biosimilars/News | Posted 21/02/2014

US generics company Alvogen announced on 13 February 2014 that it had launched the infliximab biosimilar Inflectra in Central and Eastern Europe in collaboration with Hospira.

EMA approves follitropin alfa biosimilar

Biosimilars/News | Posted 14/02/2014

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 23 January 2014 that it had recommended the granting of a marketing authorization for biosimilar infertility treatment Bemfola (follitropin alfa).

Trastuzumab ‘similar biologic’ to be launched in India

Biosimilars/News | Posted 24/01/2014

India-based Biocon announced on 18 January 2013 that it was introducing its trastuzumab ‘similar biologic’ CANMAb to the Indian market.

Mylan launches trastuzumab ‘similar biologic’ in India