Menu

Biosimilars/News

Law V13C29

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].

Clinical Trials 2 V13K29

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.

picture07

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.

Patent 1 V13E17

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.

Business Aquisition V13F07

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.

Biologicals 2 V12K16

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.

Shaking hands V13D29

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.

Teamwork check mark V13D12

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).

Insulin 1 V13C03

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.

picture 138

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.

Trastuzumab Herceptin V13D12

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 V14A10

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.

Adalimumab 2 V14A10

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.

Biosimilars V13E10

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.

Anaemia 2 V13J18

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).

Trastuzumab Herceptin V13D12

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’.

Brazil flag V13C03

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.

Approved V13G05

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.

picture23

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).

Patent 2 V13E31

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).