Biosimilars/News

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.

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

Biosimilars/News | Posted 07/02/2014

Generics giant Mylan announced on 3 February 2014 that its subsidiary, Mylan Pharmaceuticals Private Limited, had launched its trastuzumab ‘similar biologic’ Hertraz to the Indian market.

Roche wins case against Herceptin ‘similar biologics’ producers

Biosimilars/News | Posted 14/02/2014

Generic drugmaker Mylan and its partner Biocon have been successfully sued by Roche for failing to carry out sufficient clinical trials on ‘similar biologics’ of the breast cancer blockbuster Herceptin (trastuzumab). Mylan and Biocon had recently announced plans to launch their ‘similar biologics’ in India [1, 2].

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.

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.