Pharma News
Coherus signs licensing deal for bevacizumab biosimilar in the US
US-based Coherus BioSciences (Coherus) announced on 13 January 2020 that it had entered into a licensing agreement with Chinese biopharmaceutical firm Innovent Biologics (Innovent) for its bevacizumab product, IBI305.
Top 10 most read GaBI Online articles in 2019
It has once again been a busy year for biosimilars. One of the most important milestones for biosimilars in 2019 was the World Health Organization (WHO) pilot programme to prequalify rituximab and trastuzumab biosimilars. Other subjects of interest for biosimilars were US Food and Drug Administration (FDA) and European Medicines Agency (EMA) approvals, naming and regulation of biosimilars, as well as biosimilar guidance, uptake and switching.
Mundipharma and Samsung Bioepis partner for biosimilars in Hong Kong and Taiwan
Mundipharma announced on 13 January 2020 that it had entered into a partnership with Korea-based Samsung Bioepis (Samsung and Biogen’s joint venture) to commercialize four biosimilar candidates from Samsung Bioepis in Hong Kong and Taiwan.
Japanese firms to collaborate on Eylea biosimilar
Japanese pharmaceutical firms Gene Techno Science and Kishi Kasei announced on 2 December 2019 an agreement for the joint development of an aflibercept biosimilar, a treatment for macular degeneration to rival the reference drug Eylea.
Samsung Bioepis expands biosimilars agreement with Biogen
Korean biosimilars giant Samsung Bioepis has extended its commercialization agreement with Biogen to include biosimilars to two ophthalmology drugs, Lucentis (ranibizumab) and Eylea (aflibercept). The agreement also allows Biogen to commercialize Samsung’s blockbuster anti-inflammatories in Europe for an additional five years.
Alvotech signs agreements with Stada and Yas Holding
Alvotech has entered into a strategic biosimilars collaboration with German company Stada. The company has also announced a significant investment from Abu Dhabi-based company Yas Holding for the exclusive supply of biosimilars in the Middle East and North Africa.
Lupin to sell its Japanese arm and Sandoz to acquire Aspen’s Japanese business
On 11 November 2019, India-based Lupin announced that it has agreed to sell its entire stake in its Japanese subsidiary Kyowa Pharmaceutical Industry Co to Japan-based private equity firm Unison Capital for an enterprise value of Yen 57.36 billion.
Alvogen gains exclusive rights to market parathyroid biosimilar in three countries
American pharmaceuticals firm Alvogen has announced exclusive commercialization agreements to distribute and market a teriparatide biosimilar in Canada, Israel and South Korea.
Biocon acquires Pfizer research facility and signs licensing agreement with Evotec
India-based biologicals specialist Biocon has announced the acquisition of a research and development facility from Pfizer Healthcare India Ltd and signed a strategic licensing agreement for an early-stage biosimilar with Evotec Biologics.
Lupin to sell Japanese injectables business and collaborates with German drugmaker on anticancer treatment
India-based generics manufacturer Lupin Ltd – the eighth biggest generics company in the world – has announced the sale of its Japanese injectables business to a subsidiary of the United Arab Emirates’ (UAE) largest pharmaceutical manufacturer.
Further collaborations formed to penetrate China’s generics market
The Chinese pharmaceutical market is the second largest in the world, and generic drugs make up 70% of its value. Continued growth of China’s generics industry is anticipated owing to rapid population ageing and government policies to promote generics [1]. It is therefore not surprising that generic drug manufacturers are keen to penetrate this market, and indeed over the last few months there have been a number of collaborations with this objective [2-4]. Most recently, Japanese drugmakers Eisai and Nichi-Iko Pharmaceutical entered into a collaboration agreement to sell generic drugs in China, while Sun Pharmaceutical Industries (Sun Pharma) partnered with China Medical System Holdings (CMS) to develop and commercialise generics in China.
Celltrion contracts Lonza to manufacture autoimmune treatment Remsima
South Korean biosimilars manufacturer Celltrion have announced a deal with Swiss contract manufacturing organisation (CMO) Lonza to produce its autoimmune biosimilar Remsima at a facility in Singapore.
Shanghai Pharma and Russia’s Biocad form joint venture to sell cancer and autoimmune drugs in China
Shanghai Pharmaceuticals Holding and Russia’s Biocad Pharmaceutical have agreed to form a joint venture to develop, manufacture and market cancer and autoimmune disease treatments in China.
Sandoz makes deal with Polpharma for natalizumab biosimilar
Sandoz, the generics division of Novartis, and Poland-based Polpharma Biologics announced on 3 September 2019 that they had signed a worldwide agreement giving Sandoz commercialization rights to Polpharma’s candidate natalizumab biosimilar (PB006).
Huons enters biosimilar market while private equity firm PAG invests in Hisun BioRay
Huons has announced its plans to enter the biosimilar market, and private equity firm PAG has acquired a controlling interesting in Hisun Pharmaceutical’s biopharmaceutical subsidiary, Hisun BioRay.
Alvotech and Cipla Gulf partnership announced
On 29 July 2019, pharmaceutical companies Alvotech and Cipla Gulf announced that they have entered into an exclusive partnership for the commercialization of an adalimumab biosimilar (AVT02), in a selection of emerging markets.
Agreement between Hikma and Civica to reduce US generic drug shortages
Hikma Pharmaceuticals Plc and Civica Rx announced a five-year agreement on 23 July 2019. Under the agreement, Hikma will manufacture and supply 14 essential sterile injectable medications for Civica. It will use Hikma's abbreviated new drug applications (ANDAs) and Civica's labelling and National Drug Code (NDC). The full list of medications included in the agreement, that are often in short supply in US hospitals, will be publicly announced in the near future. Initial shipments are expected by the end of 2019.
WHO essential medicines list: new lung cancer medicines rejected
The World Health Organization’s (WHO) list of ‘essential medicines’, received a biennial update on 9 July 2019. It added 28 drugs but left out several new treatments for lung cancer.
Prestige and Pharmapark make deal for trastuzumab biosimilar
Singapore-based Prestige BioPharma (Prestige) and Russia-based Pharmapark announced on 8 July 2019 that they had signed an exclusive partnership and supply agreement for Prestige’s candidate trastuzumab biosimilar (HD201) in Russia.
Celltrion and Nan Fung Group form joint venture for copy biologicals in China
South Korean biosimilars firm Celltrion and Hong Kong-based Nan Fung Group announced on 18 July 2019 that the two companies had formed a joint venture, Vcell Healthcare, with the aim of developing and commercializing copy biologicals in China.
STADA and Xbrane strengthen biosimilars collaboration
German generics giant Stada Arzneimittel (Stada) and Swedish biotech company Xbrane Bioscience (Xbrane) announced on 31 May 2019 that they have expanded their strategic biosimilar development partnership.
Boehringer Ingelheim finally signs licensing deal for Humira biosimilar
Boehringer Ingelheim (Boehringer) has finally given in and signed a licensing deal for its Humira biosimilar, Cyltezo (adalimumab), in the US.
Sandoz and EirGenix make deal for trastuzumab biosimilar
Sandoz, the generics division of Novartis, announced on 30 April 2019 that it had signed an agreement with Taiwan’s EirGenix to market a proposed trastuzumab biosimilar.
Alvotech signs agreement for ustekinumab biosimilar Stelara in Japan
Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 9 April 2019 that they had made a binding agreement for the exclusive partnership and supply to commercialize Alvotech’s ustekinumab biosimilar, Stelara, in Japan.
Alteogen gains patent on SC trastuzumab biosimilar
South Korean biologicals company Alteogen announced on 27 March 2019 that it had gained a patent for a subcutaneous version (ALT LS2) of its candidate trastuzumab biosimilar (ALT L2).
First Chinese biologicals maker receives EMA GMP certification
China-based WuXi Biologics announced on 20 March 2019 that it had received good manufacturing practice (GMP) certification from the European Medicines Agency (EMA).
Belgian companies make biosimilars agreement
Belgian companies SYnAbs and Univercells announced on 20 April 2019 the signing of a service agreement for an undisclosed monoclonal antibody biosimilar.
Celltrion has renewed success with leukaemia biosimilar Truxima and expands markets in Europe and Latin America
In recent months, South Korean biosimilars firm Celltrion has announced a series of successes, including winning a patent case against Samsung Biogen and expansions in the European and Latin American markets.
Novo Nordisk granted exclusivity on GLP-1 agonist Victoza until 2023
Novo Nordisk has announced a settlement with Teva Pharmaceuticals (Teva) giving the company at least four years before it has to compete with biosimilar versions of its diabetes injectable Victoza (liraglutide).
AbbVie and Coherus sign licensing deal for Humira biosimilar
Coherus BioSciences (Coherus) announced in January 2019 that it had entered into global settlement agreements with AbbVie which resolve all pending disputes related to CHS-1420, Coherus’s proposed biosimilar of AbbVie’s Humira (adalimumab).
Under the terms of the settlement, Coherus will have global non-exclusive licence rights to commercialize CHS-1420 and will pay royalties to AbbVie. The licence period for CHS-1420 in the US will begin on 15 December 2023.
Fujifilm acquires Biogen Hillerød facility for US$890 million
On 12 March 2019, Biogen announced that it had entered into an agreement with Fujifilm Corporation under which Fujifilm will acquire Biogen Manufacturing ApS from Biogen for up to US$890 million in cash. Biogen Manufacturing ApS is a large-scale biologicals manufacturing site located in Hillerød, Denmark (Biogen Hillerød). Biogen Hillerød will become Fujifilm's fourth biopharmaceutical contract development and manufacturing site upon closure of this transaction, which is expected in August 2019 subject to closing conditions. The existing workforce at the site, consisting of approximately 800 employees, will continue employment under Fujifilm.
Boehringer wins access to Humira documents as Janssen’s Remicade is relisted in Quebec
Boehringer Ingelheim is the only biosimilar manufacturer still challenging AbbVie’s Humira (adalimumab) patents in court, and has just won a legal battle to gain access to documents AbbVie has fought hard to keep private. Meanwhile, Janssen has had Remicade (infliximab) reinstated on Quebec’s List of Medications after a decision by the Minister of Health and Social Services to “delist” Remicade was declared invalid and overturned.
Sandoz makes biological deal in China
Sandoz has made a deal for copy biological in China in December 2018, and received approval of an extra indication for its biosimilar etanercept in January 2019.
AbbVie makes more deals delaying adalimumab biosimilars in the US
Last update: 14 December 2018
US-based pharma giant AbbVie has signed yet more deals with biosimilars makers regarding biosimilar versions of its blockbuster arthritis drug Humira (adalimumab).
Samsung Bioepis makes deals for copy biologicals in China
Samsung Bioepis has made deals with two Chinese firms to expand its business in the country.
Fuji Pharma acquires stake in Alvotech
Iceland-based biopharmaceutical company Alvotech announced on 19 November 2018 that Japan-based Fuji Pharma was investing in the company.
Glenmark makes deal for ophthalmic generics
Indian generics maker Glenmark Pharmaceuticals (Glenmark) has entered into an exclusive agreement with South Korea’s Sam Chun Dang Pharm (SCD) to develop, manufacture and market a portfolio of generic ophthalmic products in the US and Canada.
Top 10 most read GaBI Online articles in 2018
A review of the important events for biosimilars during 2018 are presented in this article. Some of the most memorable events for biosimilars in 2018 were the rejections by the US Food and Drug Administration (FDA) of four biosimilars and the agency’s update on its naming guideline for biologicals. Other subjects of interest for biosimilars were European Medicines Agency approvals, the US biosimilars market, biosimilar policies in Europe, position statements on biosimilars and interchangeability and switching.
Samsung BioLogics sues Korea’s FSC over accounting discrepancies
Samsung BioLogics is fighting back against allegations of accounting fraud and has launched a lawsuit against the South Korean financial authority, the Financial Services Commission (FSC).
Health care in Iraq saves money by incorporating off-patent biologicals
Iraq is one of many countries determined to increase its budget savings by replacing appropriate originator biologicals with off-patent biologicals. This is due to the recognition of the proven impact off-patent biologicals have on the financial burden of healthcare systems worldwide [1, 2].
