Biosimilars/News

Japanese approval for insulin glargine biosimilar

Biosimilars/News | Posted 30/01/2015

Partners Eli Lilly and Boehringer Ingelheim confirmed on 19 January 2015 that they had received Japanese regulatory approval for their biosimilar insulin glargine product (LY2963016).

Norwegian study may be slowing adoption of biosimilar infliximab

Biosimilars/News | Posted 24/10/2014

Norway is funding clinical studies in which patients will be switched from originator biological drugs to biosimilars [1]. However, some have speculated that the NOR-SWITCH study is actually slowing the adoption of biosimilar infliximab in Norway.

Adalimumab similar biologic launched in India

Biosimilars/News | Posted 30/01/2015

Indian generics maker Zydus Cadila announced on 9 December 2014 the launch of its adalimumab similar biologic in India.

Mabion starts phase III trial for rituximab biosimilar

Biosimilars/News | Posted 23/01/2015

Polish biologicals company Mabion announced on 25 November 2014 that it had received the consent of the appropriate regulatory authorities in Croatia, Bosnia and Herzegovina, Serbia and Poland to start a phase III clinical trial for its rituximab biosimilar (MabionCD20) in patients with diffuse large B-cell lymphoma.

Hospira submits application to FDA for epoetin alfa biosimilar

Biosimilars/News | Posted 16/01/2015

US-based injectables specialist Hospira announced on 12 January 2015 that it had submitted a Biologics License Application (BLA) to the US Food and Drug Administration (FDA) for its epoetin alfa biosimilar Retacrit.

Apotex pegfilgrastim biosimilar under FDA review

Biosimilars/News | Posted 16/01/2015

Canada-based Apotex announced on 17 December 2014 that the US Food and Drug Administration (FDA) had accepted for filing the company’s application for a biosimilar version of Amgen’s Neulasta (pegfilgrastim).

First infliximab ‘similar biologic’ launched in India

Biosimilars/News | Posted 09/01/2015

India-based Ranbaxy Laboratories (Ranbaxy) announced on 1 December 2014 that it had launched its infliximab ‘similar biologic’, BOW015 in India. This is the first infliximab similar biologic to be launched in India.

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).

Amgen starts phase III trial for biosimilar rituximab

Biosimilars/News | Posted 26/09/2014

Biologicals major Amgen is carrying out a global phase III clinical trial for a biosimilar version of Roche’s blockbuster arthritis/non-Hodgkin’s lymphoma drug MabThera/Rituxan (rituximab).

Biosimilar infliximab launched in Japan

Biosimilars/News | Posted 05/12/2014

Japanese pharma firm Nippon Kayaku announced on 28 November 2014 the launch of its infliximab biosimilar, Infliximab BS, in Japan.

Biocad and Epirus to invest in follow-on biological products in Brazil

Biosimilars/News | Posted 31/10/2013

Biocad Russia is to open a US$40 million facility to produce three follow-on biological products in Brazil.

Momenta gains approval to start biosimilar adalimumab trial in Europe

Biosimilars/News | Posted 12/12/2014

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 December 2014 the acceptance by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) of a clinical trial application to initiate a clinical trial for its adalimumab biosimilar, M923.

Stada to in-license adalimumab biosimilar

Biosimilars/News | Posted 05/12/2014

German generics giant Stada Arzneimittel (Stada) announced on 18 November 2014 that it was in negotiations to in-licensing an adalimumab biosimilar.

Amgen expands biosimilars programme

Biosimilars/News | Posted 28/11/2014

Biologicals major Amgen is expanding its biosimilars portfolio to include nine different molecules.

Amgen launches biosimilars info app

Biosimilars/News | Posted 21/11/2014

Biologicals major Amgen has launched an app which aims to provide a source of information about biosimilars.

Amgen sues Sandoz over filgrastim biosimilar

Biosimilars/News | Posted 14/11/2014

Biologicals major Amgen is suing Sandoz to stop the biosimilars maker from marketing a biosimilar of its top-selling product Neupogen (filgrastim) in the US. Amgen claims in its lawsuit that Sandoz did not follow the rules for biosimilar development.

Study into switching from Aranesp to biosimilar epoetin alfa

Biosimilars/News | Posted 07/11/2014

Biologicals major Amgen has started recruiting patients for a clinical trial to study the effect of switching patients from the originator biological Aranesp (darbepoetin alfa) to biosimilar epoetin alfa, in other words, from a long-acting to a short-acting epoetin.

Coherus sells shares to raise funds for biosimilars programme

Biosimilars/News | Posted 07/11/2014

US-based biosimilars developer Coherus BioSciences (Coherus) is looking for further funding for its biosimilar programme. The company is preparing to sell shares in the company in order to raise funds to get three of the biosimilars in its pipeline through clinical trials.

Stada in-licenses teriparatide biosimilar

Biosimilars/News | Posted 17/10/2014

German generics giant Stada Arzneimittel (Stada) announced on 13 October 2014 that it had made a deal to in-licensing a teriparatide biosimilar.

LG Life Sciences and Mochida make deal for adalimumab biosimilar

Biosimilars/News | Posted 31/10/2014

South Korea-based LG Life Sciences and Japan-based Mochida Pharmaceutical (Mochida) announced on 15 October 2014 that they had signed a deal to co-develop and commercialize an adalimumab biosimilar for the Japanese market.

Epirus and Livzon collaborate on copy biologicals for China

Biosimilars/News | Posted 10/10/2014

US-based Epirus Biopharmaceuticals (Epirus) announced on 25 September 2014 that it had signed a collaboration agreement with Chinese biotechnology company Livzon Mabpharm (Livzon).

Infliximab ‘similar biologic’ receives Indian approval

Biosimilars/News | Posted 03/10/2014

US-based biologicals company Epirus Biopharmaceuticals (Epirus) announced on 15 September 2014 that it had received final marketing and manufacturing approvals for its infliximab similar biologic, BOW015, from the Drug Controller General of India (DCGI).

Mylan starts phase III trials for biosimilar insulin glargine

Biosimilars/News | Posted 03/10/2014

Generics maker Mylan has started two US phase III clinical trials for a biosimilar version of French drugmaker Sanofi’s diabetes drug Lantus (insulin glargine).

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.

Roche updates position on biosimilars

Biosimilars/News | Posted 26/09/2014

Originator pharma company Roche has updated its position statement on biosimilars, stating that ‘biosimilars are not quite the same’.

Pegteograstim biological approved in South Korea

Biosimilars/News | Posted 19/09/2014

South Korean biologicals company, Green Cross, announced on 18 August 2014 that it had received marketing authorization from South Korea’s Ministry of Food and Drug Safety (MFDS) for its pegteograstim biological Neurapeg.

European approval for biosimilar insulin

Biosimilars/News | Posted 12/09/2014

Partners Eli Lilly and Boehringer Ingelheim, announced on 10 September 2014 that they had received European Commission (EC) approval for its biosimilar insulin glargine product Abasria (LY2963016), a first for Europe.

Infliximab biosimilar to be distributed by Mundipharma

Biosimilars/News | Posted 05/09/2014

Celltrion’s infliximab biosimilar Remsima will be distributed in Belgium, Germany, Italy, Luxembourg, The Netherlands and UK, exclusively by Mundipharma International and its independent associated companies. Remsima is a biosimilar of Johnson and Johnson (J&J) and Merck’s anti-inflammatory blockbuster Remicade (infliximab).

FDA receives application for monoclonal antibody biosimilar

Biosimilars/News | Posted 29/08/2014

South Korean biotechnology company Celltrion announced on 11 August 2014 that the company had, on 8 August 2014, completed the filing procedure to obtain US Food and Drug Administration (FDA) approval for its infliximab biosimilar.

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.

FDA grants tentative approval for insulin treatment

Biosimilars/News | Posted 22/08/2014

On 18 August 2014, the US Food and Drug Administration (FDA) granted tentative approval for a new insulin glargine product (LY2963016).

More biosimilars collaborations on the cards

Biosimilars/News | Posted 22/08/2014

Collaborations for biosimilars are still in vogue, with the latest companies making deals being PlantForm Corporation (PlantForm) with PharmaPraxis and Oncobiologics and Laboratorios Liomont.

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.