Biosimilars/News

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.

Biosimilar merger for Epirus and collaboration for Catalent

Biosimilars/News | Posted 09/05/2014

Mergers and collaborations are still in vogue in the biosimilars arena. The latest firms to announce deals are Epirus Biopharmaceuticals (Epirus), which will merge with Zalicus; and Catalent, which has agreed to a biosimilar development collaboration with Zhejiang Hisun Pharma.

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.

Lupin and Yoshindo start biosimilars joint venture

Biosimilars/News | Posted 02/05/2014

Indian generics’ manufacturer Lupin Pharmaceuticals (Lupin) announced on 21 April 2014 that the company had entered into a joint venture with Japanese generics maker Yoshindo for a biosimilars joint venture in Japan.

Brazil’s ANVISA approves Cristália for production of ‘follow-on biological products’

Biosimilars/News | Posted 25/04/2014

Brazilian drugmaker Cristália has taken a step closer to its goal of producing ‘follow-on biological products’ domestically after receiving clearance from the country’s drug regulator, the Brazilian Health Surveillance Agency (Agência Nacional de Vigilância Sanitária, ANVISA).

FDA to review insulin biosimilar

Biosimilars/News | Posted 31/01/2014

Eli Lilly and Boehringer Ingelheim announced on 20 December 2013 that the US Food and Drug Administration (FDA) had accepted their New Drug Application (NDA) for a biosimilar insulin product.

Alvotech invests US$250 million in biosimilars

Biosimilars/News | Posted 24/01/2014

Iceland-based biopharmaceutical company Alvotech announced on 5 December 2013 that it would invest US$250 million to build a plant in Reykjavik for the development and manufacture of a portfolio of biosimilar monoclonal antibodies.

Biosimilar trastuzumab approved in Korea

Biosimilars/News | Posted 17/01/2014

South Korean biotechnology company Celltrion announced on 15 January 2014 that it had received approval for its biosimilar monoclonal antibody Herzuma (trastuzumab) with the Korean Ministry of Food and Drug Safety (MFDS, formerly Korea Food and Drug Administration).

Remsima approved in Colombia

Biosimilars/News | Posted 10/01/2014

On 16 December 2013, Colombia’s National Institute of Food and Drug Monitoring (INVIMA – Instituto Nacional de Vigilancia de Medicamentos Y Alimentos) announced the approval of Remsima (infliximab) – the first producto bioterapéutico similar (similar biotherapeutic product) to be approved in Colombia.

Sandoz starts phase III biosimilar adalimumab trial

Biosimilars/News | Posted 10/01/2014

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 18 December 2013 the start of a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from psoriasis.

Teva launches new biologicals in Europe and US

Biosimilars/News | Posted 13/12/2013

Teva Pharmaceutical Industries (Teva) announced on 18 November 2013 the first EU launch for its new long-acting filgrastim molecule Lonquex (lipegfilgrastim) in Germany and the launch of its short-acting granulocyte colony-stimulating factor (G‑CSF) Granix (tbo-filgrastim) in the US.

Avesthagen and Elpen make deal for biosimilar darbepoetin alfa

Biosimilars/News | Posted 13/12/2013

Indian life science company Avesthagen Pharma (Avesthagen) announced on 19 November 2013 that it had entered into a biosimilars agreement with Greece-based Elpen Pharmaceutical (Elpen).

Indian regulator approves first trastuzumab ‘similar biologic’

Biosimilars/News | Posted 29/11/2013

India’s drug regulator, the Drugs Controller General of India (DCGI), has granted marketing approval for the world first trastuzumab ‘similar biologic’.

Merck Serono to transfer technology for six similar biotherapeutic products to Brazil

Biosimilars/News | Posted 29/11/2013

The Brazilian Ministry of Health (Ministério da Saúde) announced on 7 November 2013 a partnership between Brazil’s Bionovis, Fiocruz and Instituto Vital Brazil (IVB) with Germany’s Merck Serono for the production of six ‘similar biotherapeutic products’ for cancer and arthritis.

EMA approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 05/07/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 28 June 2013 that it had recommended granting of marketing authorization for the first monoclonal antibody biosimilar, marketed under two trade names, Remsima (Celltrion) and Inflectra (Hospira) with different marketing authorization, different EPAR, and different packaging.

Teva gains FDA approval for three-times-a-week Copaxone

Biosimilars/News | Posted 14/02/2014

Teva Pharmaceutical Industries (Teva) announced on 28 January 2013 the generics giant had gained US Food and Drug Administration (FDA) for a new formulation of its blockbuster multiple sclerosis drug Copaxone (glatiramer acetate).

Biosimilars ruling has implications for future patent challenges

Biosimilars/News | Posted 15/11/2013

Biosimilars manufacturers may not be able to make early challenges on biologicals patents according to a ruling which rejected Sandoz’s request to invalidate patents for Amgen’s blockbuster autoimmune disease treatment Enbrel (etanercept). This appears to be the first court decision interpreting the patent litigation provisions of the Biologics Price Competition and Innovation Act (BPCI Act).

Stada in-licenses biosimilar filgrastim

Biosimilars/News | Posted 08/11/2013

German generics giant Stada Arzneimittel (Stada) announced on 28 October 2013 that it was strengthening its activities in the biosimilars area by in-licensing a biosimilar filgrastim product from Canada-based Apotex.

EC approves first monoclonal antibody biosimilar

Biosimilars/News | Posted 13/09/2013

Hospira announced on 10 September 2013 that it had received European Commission (EC) approval for its biosimilar monoclonal antibody infliximab (Inflectra), a first in Europe.

Biocad signs deal for biosimilar darbepoetin alpha in Turkey

Biosimilars/News | Posted 06/09/2013

Russian biosimilars manufacturer Biocad has signed a definitive agreement with Turkish oncology specialist Koçak Farma for the export of biosimilar darbepoetin alpha active pharmaceutical ingredients (APIs).

Amgen to start phase III trial for biosimilar adalimumab

Biosimilars/News | Posted 27/09/2013

Biotechnology giant Amgen is to start a phase III clinical trial for a biosimilar version of adalimumab in patients suffering from severe rheumatoid arthritis according to the EU Clinical Trials Register.

EMA approves biosimilar follitropin alfa and somatropin

Biosimilars/News | Posted 20/09/2013

The European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP) announced on 31July 2013 that it had recommended granting of marketing authorization for a biosimilar follitropin alfa. While on 9 September 2013, the agency announced the approval of a new somatropin biosimilar.

Failed biosimilars company to be sold

Biosimilars/News | Posted 20/09/2013

The assets of biosimilars developer Elona Biotechnologies (Elona) will be auctioned on 27 September 2013 unless sold before 6 September 2013.

Celltrion applies for biosimilar infliximab approval in Japan

Biosimilars/News | Posted 13/09/2013

On 11 September 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of Remsima, its biosimilar infliximab monoclonal antibody, with Japan’s Ministry of Health, Labour and Welfare (MHLW).

Baxter and Coherus to collaborate on biosimilars

Biosimilars/News | Posted 06/09/2013

Baxter International (Baxter) has made another agreement for biosimilars, this time with fledgling biotech company Coherus Biosciences (Coherus).

Roche abandons Herceptin patent in India

Biosimilars/News | Posted 30/08/2013

Swiss-based pharma giant Roche has decided not to pursue its patent for its blockbuster cancer drug Herceptin (trastuzumab) in India, opening the market to biosimilars.

Indian firms chasing ‘similar biologic’ Herceptin

Biosimilars/News | Posted 30/08/2013

Following the decision by Swiss-based pharma giant Roche not to pursue its patent for Herceptin (trastuzumab) in India [1] it seems that a whole host of Indian firms are lining up to get their ‘similar biologic’ of the blockbuster cancer drug to market.

Apotex breaking into the North American and European G-CSF markets

Biosimilars/News | Posted 23/08/2013

A new biosimilar filgrastim is poised to enter the important granulocyte colony-stimulating factor (G-CSF) market following a positive opinion from the European Medicines Agency’s (EMA’s) Committee for Medicinal Products for Human Use (CHMP).

EMA approval for Teva’s long-acting recombinant G-CSF

Biosimilars/News | Posted 23/08/2013

The European Medicines Agency (EMA) has granted marketing authorization for a new long-acting filgrastim – Lonquex (XM22 lipegfilgrastim) – to prevent chemotherapy-induced neutropenia in cancer patients.

AstraZeneca pursuing biosimilars with Celltrion bid

Biosimilars/News | Posted 16/08/2013

Pharma giant AstraZeneca is rumoured to be ready to join the race for biosimilars with a bid for South Korean biotechnology company Celltrion.

Teva and Lonza end biosimilars agreement

Biosimilars/News | Posted 09/08/2013

Despite Switzerland-based API producer Lonza denying reports back in April 2013 that it was considering backing out of its biosimilars joint venture with Israeli generics giant Teva Pharmaceutical Industries (Teva) that is just what has happened.

EMA reviewing biosimilar insulin application

Biosimilars/News | Posted 02/08/2013

According to EMA’s list of applications for new human medicines under evaluation by the Committee for Medicinal Products for Human Use released on 4 July 2013 the agency is now reviewing a new application for a biosimilar insulin product.

Biosimilar G-CSF prescribed more than originator

Biosimilars/News | Posted 02/08/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, announced on 22 July 2013 that its biosimilar granulocyte colony-stimulating factor (G-CSF) Zarzio (filgrastim) has overtaken the originator product in terms of prescriptions.

Sandoz to start phase III etanercept trial

Biosimilars/News | Posted 24/05/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is to start a phase III clinical trial for a biosimilar version of etanercept in patients suffering from psoriasis, according to the EU Clinical Trials Register.

Pfizer to start trial for biosimilar adalimumab

Biosimilars/News | Posted 21/06/2013

Pharma giant Pfizer is once again expanding its pipeline of biosimilars and is set to start a phase I study for its biosimilar adalimumab candidate (PF-06410293) according to ClinicalTrials.gov, the US clinical trials website.

Sandoz comments on EMA’s new draft biosimilars guidance

Biosimilars/News | Posted 21/06/2013

Sandoz, the generic drug division of Swiss drug giant Novartis, is pleased that the European Medicines Agency (EMA) has issued a draft revised guideline on non-clinical and clinical issues in biosimilar product development.

Celltrion applies for Korean approval of biosimilar trastuzumab

Biosimilars/News | Posted 07/06/2013

On 4 June 2013, South Korean biotechnology company Celltrion announced that it had filed for approval of its biosimilar candidate CT-P6 with the Korean Ministry of Food and Drug Safety (MFDS, formerly the Korea Food and Drug Administration).

Russia to harmonize biologicals regulations

Biosimilars/News | Posted 31/05/2013

International regulatory bodies and the drug industry met in Moscow on 15 May 2013 to discuss how to harmonize Russia’s regulatory standards for biologicals with the rest of the world to develop a framework for pharma companies developing biologicals and biosimilars in Russia.

Huahai and Oncobiologics make biosimilars deal

Biosimilars/News | Posted 24/05/2013

US-based Oncobiologics announced on 8 May 2013 that it had signed an alliance agreement for the development, manufacture and commercialization of biosimilar monoclonal antibodies with Zhejiang Huahai Pharmaceutical (Huahai).

Agila Biotech and Pfenex make biosimilars deal

Biosimilars/News | Posted 17/05/2013

Agila Biotech, a subsidiary of India-based Strides Arcolab, and US-based biotech firm Pfenex announced on 16 April 2013 that they had entered into a joint venture for biosimilars.