Pharma News
Eagle moves into biosimilars with Arsia acquisition
Specialty pharmaceuticals company Eagle Pharmaceuticals (Eagle) has signed an agreement to acquire Arsia Therapeutics (Arsia), the biotechnology company behind cutting-edge technology that enables intravenous drugs to be administered by injection.
Top 10 most read GaBI Online articles in 2016
It has once again been a busy year for biosimilars. An important milestone for biosimilars in 2016 was the adoption by the European Medicines Agency (EMA) of new guidance on monitoring biologicals. While the US Food and Drug Administration (FDA) approvals of infliximab and adalimumab biosimilars were also important events in 2016. Other subjects of interest for biosimilars were the differences between biosimilars and reference biologicals, biosimilarity and switching biosimilars. Biosimilars remain the hot topic for GaBI Online during 2016.
Strategic biologicals alliance between Sanofi and JHL Biotech in China
Sanofi and JHL Biotech (JHL) announced on 5 December 2016 that they were forming a strategic biologics alliance in China. The two companies will be collaborating on the development and commercialization of biological therapeutics in China, with potential for further international expansion.
Sun Pharma to acquire Russia’s Biosintez
Sun Pharmaceutical Industries (Sun Pharma) announced on 23 November 2016 its acquisition of Russian pharmaceutical company JSC Biosintez at a cost of US$24 million, demonstrating the company’s commitment to the Russian market.
India’s Cipla to establish biosimilars facility in South Africa
Indian generics maker Cipla has announced a deal to set up South Africa’s first biosimilars manufacturing facility, at an estimated cost of over US$91 million.
Richter and DM Bio make deal for trastuzumab biosimilar
Hungary-based Gedeon Richter (Richter) announced on 19 October 2016 that it had signed a technology transfer and in-licensing agreement with South Korea-based biologicals specialist DM Bio for the development and commercialization of DM Bio’s trastuzumab biosimilar.
China’s CFDA rejects more than 80% of drug applications
Data released by China Food and Drug Administration (CFDA) revealed that between January 2015 and January 2016, 1,184 drug applications submitted to CFDA were rejected or withdrawn due to incomplete or fraudulent clinical data.
Dr Reddy’s expands collaboration with Amgen in India
Generics manufacturer Dr Reddy’s Laboratories (Dr Reddy’s) is expanding its collaboration with US-based biologicals specialist Amgen with an agreement to market and distribute three of Amgen’s biological medicines in India in the therapy areas of oncology and osteoporosis.
Sun Pharma announces Japanese distribution pact with Mitsubishi Tanabe
Sun Pharmaceutical Industries (Sun Pharma) has announced it will transfer marketing authorizations for 14 of its prescription drugs to Mitsubishi Tanabe Pharma (Mitsubishi Tanabe), allowing the company to manufacture and market them in Japan.
Pfizer antibiotics banned across the EU
An inspection by the UK Medicines and Healthcare Products Regulatory Agency (MHRA) has resulted in the ban of several drugs produced by a Pfizer manufacturing site in India.
EMA reports ‘critical deficiencies’ in Chinese API producer Jinan Jinda
A recent European Medicines Agency’s (EMA) follow up on Jinan Jinda Pharmaceutical Chemi Co Ltd (Jinan Jinda) revealed that the Chinese pharmaceutical company is far off meeting EU standards.
Fosun Pharma to acquire Gland in largest acquisition by a Chinese company in India
Shanghai Fosun Pharmaceutical Group Co Ltd (Fosun Pharma) will acquire an 86% stake in Gland Pharma Ltd for an estimated US$1.2–1.5 billion in China’s largest ever takeover of a company in India.
Mylan receives EU go-ahead to purchase Meda, with conditions
The European Commission (EC) has approved the multi-billion dollar acquisition of Swedish specialty pharmaceutical company Meda by Mylan, one of the world’s largest generics and specialty pharmaceutical companies, subject to certain conditions.
Teva to acquire US-based generics maker Anda
Israeli generics giant Teva Pharmaceutical Industries (Teva) announced on 3 August 2016 that it had entered into a definitive agreement to buy US generics business Anda from Allergan.
Amgen and Daiichi Sankyo make deal for biosimilars in Japan
US-based biologicals specialist Amgen and Japan-based Daiichi Sankyo announced on 13 July 2016 that they had made an exclusive agreement to commercialize nine biosimilars in Japan.
Teva generics being snapped up by rivals
There has been a rush on Teva Pharmaceutical Industries (Teva) generics recently, with another round of companies clambering over the pickings.
UK’s DoH says most medicines do not experience shortages
The UK’s Department of Health (DoH) has said that the ‘vast majority’ of prescriptions in the country are not subject to supply problems.
AMRI acquires API maker Euticals
US-based Albany Molecular Research Inc (AMRI) announced on 5 May 2016 that it had entered into a definitive agreement to buy Prime European Therapeuticals, also known as Euticals.
Lannett to co-develop biosimilar insulin product with Chinese partner
US generics maker Lannett Company (Lannett) announced on 22 April 2016 plans to co-develop a biosimilar insulin product for the US market with its strategic partner in China, Yichang HEC Changjiang Pharmaceutical (Yichang), which is part of the HEC Group.
Teva and Takeda establish ‘Teva Takeda Yakuhin’ in Japan
Israeli generics giant Teva Pharmaceutical Industries (Teva) and Japan-based Takeda Pharmaceutical Company (Takeda) have formed a joint company ‘Teva Takeda Yakuhin’ to produce and sell off-patented medicines in Japan.
SGS and DiscoverX to collaborate on bioassays for biosimilars
Contract solutions provider SGS announced on 30 March 2016 that it had entered into a collaboration with innovative life science company DiscoverX.
Dr Reddy’s and TRPharm collaborate on biosimilars in Turkey
Generics giant Dr Reddy’s Laboratories and Turkish pharma start-up firm TRPharm announced on 10 March 2016 that they had entered into a strategic collaboration agreement for a portfolio of biosimilars in Turkey.
Partnership between PlantForm and Guelph University for biosimilar trastuzumab
Canada-based PlantForm Corporation (PlantForm) announced on 3 March 2016 that it had been awarded a Collaborative Research and Development Grant from the Natural Sciences and Engineering Research Council of Canada (NSERC).
Oncobiologics and Premier make biosimilars deal
US biotechnology company Oncobiologics and healthcare performance improvement alliance Premier announced on 3 March 2016 that they had entered into a collaboration aimed at increasing the use of biosimilars.
Strides Shasun acquires Australian and Kenyan generics makers
India-based generics manufacturer Strides Shasun has increased its generics portfolio and presence across the globe with two new acquisitions.
Mylan to acquire Swedish drugmaker Meda
US generics manufacturer Mylan announced on 10 February 2016 that it had made a deal worth US$9.9 billion (for shares and debt) to buy Swedish drugmaker Meda.
Fuji Pharma gains rights to darbepoetin alfa biosimilar in Japan
Japan-based Fuji Pharma announced on 5 January 2016 that it had signed a license agreement with Chong Kun Dang Pharmaceutical (CKD Pharma). Under the agreement, Fuji Pharma has the exclusive rights in Japan for the development, manufacture, distribution and sale of CKD Pharma’s darbepoetin alfa biosimilar (CKD‑11101).
Mylan and Momenta to jointly develop and commercialize six biosimilar products
Mylan NV has agreed an exclusive global collaboration with Momenta Pharmaceuticals Inc (Momenta) to develop, manufacture and commercialize six of Momenta's biosimilar candidates.
Eisai acquires Chinese generics maker
Japanese pharmaceutical company Eisai announced on 28 December 2015 that it had acquired Chinese generics maker Liaoning TianYi Biological Pharmaceutical.
Top 10 most read GaBI Online articles in 2015
It has been a hectic year for biosimilars. One of the most important milestones for biosimilars in 2015 was the finalization by the US Food and Drug Administration (FDA) of its regulatory guidelines for biosimilars. Other subjects of interest for biosimilars were the patent expiries of originator biologicals, clinical trials and extrapolation of indications. Biosimilars remain the hot topic for GaBI Online during 2015 and, in fact, all 10 of the most read articles concern biosimilars.
Teva and Takeda partner for generics in Japan
Israeli generics giant Teva Pharmaceutical Industries (Teva) and Japan-based Takeda Pharmaceutical (Takeda) announced on 30 November 2015 that they had made a partnership to provide generics in Japan.
Generic injectable prices stay high even after shortages resolved
Hospitals that have been struggling with shortages and subsequent high prices are now complaining that even after supply gets back to normal prices remain high.
Mylan will not be acquiring Perrigo
Generics company Mylan has failed in its lengthy multi-billion dollar hostile bid to acquire competing generics company Perrigo.
Pfizer cuts some biosimilars after Hospira deal
After completing its US$17 billion acquisition of Hospira, Pfizer is cutting some of its biosimilar collaborations with South Korean drugmaker Celltrion.
Merck Millipore to collaborate with Turkish firm on biosimilars
The Life Science division of Merck, Merck Millipore and Turkish biosimilars start-up Turgut Ilaç are to collaborate on biosimilars.
Teva acquires Mexican drugmaker Rimsa
Israeli generics giant Teva Pharmaceutical Industries (Teva) is expanding its presence in emerging markets with its acquisition of Mexico-based Representaciones e Investigaciones Medicas SA de CV (Rimsa), a specialty drugmaker with a portfolio of products and patents across Latin America.
Mylan goes after Perrigo
US generics manufacturer Mylan announced on 14 September 2015 that it had officially commenced its formal offer to acquire all outstanding ordinary shares of rival Ireland-based generics maker Perrigo Company (Perrigo).
Epirus expands biosimilars pipeline with Bioceros acquisition
US-based Epirus Biopharmaceuticals (Epirus) announced on 9 September 2015 that it has acquired Netherlands-based biopharmaceutical company Bioceros Holding (Bioceros).
UCB sells generics unit to Lannett
Belgium-based biopharmaceutical company UCB announced on 2 September 2015 that it would sell its US specialty generics business, Kremers Urban, to US generics company Lannett for US$1.23 billion in cash plus contingent payments.
US FTC clears Pfizer’s purchase of Hospira
Pharma giant Pfizer announced on 24 August 2015 that the US Federal Trade Commission (FTC) terminated the waiting period under the Hart-Scott-Rodino Antitrust Improvements Act of 1976, as amended, with respect to Pfizer’s pending acquisition of US-based injectable generics specialist and biosimilars maker Hospira.
