Pharma News
Alvotech makes deal with Fuji Pharma for biosimilars in Japan
Iceland-based biopharmaceutical company Alvotech and Japan-based Fuji Pharma announced on 19 November 2018 that they had entered into an exclusive partnership for biosimilars in Japan.
Amgen collaborates with Orion to market Amgevita in Finland
The Orion Group announced on 24 October 2018 that it will distribute Amgen’s adalimumab biosimilar in Finland.
Biosimilar partnerships for Alvotech and Pall Biotech
Partnering to develop biosimilars is still in vogue. The latest companies to join the trend include Alvotech with Changchun High & New Technology Industries Group (CCHN) and Pall Corporation’s Biotech business (Pall Biotech) with Aetos Biologics.
Mundipharma buys Spanish biosimilars maker Cinfa Biotech
UK-based Mundipharma International (Mundipharma) is strengthening its position in biosimilars with the acquisition of Spanish biosimilars maker Cinfa Biotech.
MENA mAb manufacturer AryoGen receives EU GMP approval
Iran-based AryoGen Pharmed (AryoGen) has received a Good Manufacturing Practice (GMP) certificate from the European Medicines Agency (EMA), becoming one of the first monoclonal antibody (mAb) manufacturers in the Middle East and North Africa (MENA) region to be certified [1].
Co-development deal for ranibizumab biosimilar Xlucane
German generics giant Stada and Swedish biotech company Xbrane announced on 12 July 2018 that they had entered into a co-development agreement for Xlucane, a proposed biosimilar to Lucentis (ranibizumab).
AbbVie signs another licensing deal for adalimumab biosimilar
US-based pharma giant AbbVie has signed yet another licensing deal for a biosimilar version of its blockbuster arthritis drug Humira (adalimumab).
Mylan and Lupin make deal for etanercept biosimilar
Indian generics manufacturer Lupin Pharmaceuticals (Lupin) and US-based drugmaker Mylan announced on 28 June 2018 that they had made a deal to commercialize an etanercept biosimilar.
Pfenex makes biosimilar deals with Alvogen and NT Pharma
US-based biotech firm Pfenex has made commercialization deals for its candidate teriparatide biosimilar (PF708) in China and in the US.
Amneal and mAbxience make deal for bevacizumab biosimilar
US generics maker Amneal Pharmaceuticals (Amneal) and biosimilars specialist mAbxience, a subsidiary of Spanish healthcare firm Insud Pharma (formerly the Chemo Group), announced on 23 May 2018 that they have signed an exclusive licensing and supply agreement in the US for mAbxience’s candidate bevacizumab biosimilar.
Strides and Apotex to merge Australian generics businesses
India-based generics manufacturer Strides Shasun (Strides) announced on 9 May 2018 that it had made an agreement with Canada-based Apotex to merge their Australian businesses.
Sanofi to sell Zentiva generics arm to Advent
French drugmaker Sanofi announced on 17 April 2018 that it had entered into exclusive negotiations with Advent International (Advent) under which Advent would acquire Zentiva, Sanofi’s European generics business for Euros 1.9 billion.
Mylan and Fujifilm Kyowa Kirin Biologics partner on adalimumab biosimilar
Fujifilm Kyowa Kirin Biologics announced on 11 April 2018 that it will partner with Mylan to commercialize its adalimumab biosimilar FKB327. Mylan will be granted exclusive commercialization rights for FKB327 in Europe.
Fujifilm to acquire cell culture media companies
Fujifilm is expanding its ability to develop and manufacture biologicals by acquiring a pair of cell culture media businesses owned by Japan-based JXTG Holdings for a combined US$800 million.
Stada resubmits biosimilar pegfilgrastim but stops adalimumab development
German generics giant Stada Arzneimittel (Stada) was informed on 2 March 2018 by Gedeon Richter (Richter) that the European Medicines Agency (EMA) has accepted the regulatory resubmission of its proposed pegfilgrastim biosimilar. However, in another press release the company announced that it was stopping development of its adalimumab biosimilar.
Korea’s CJ Healthcare shares biosimilar technology with China
South Korea’s CJ HealthCare, announced that it has signed a contract with China’s NCPC GeneTech Biotechnology on 31 January 2018 to export CJ-40001, a biosimilar version of darbepoetin alfa which is used for the treatment of renal anaemia. South Korea has well-established guidelines for biosimilars [1], whilst China has finalized the technical guidance for the development and evaluation of copy biologicals in February 2015 [2].
Biosimilar deals for Hikma and Lupin
Collaborations are once again the way forward when it comes to biosimilars. Jordan-based drugmaker Hikma Pharmaceuticals (Hikma) made a licensing deal with South Korean biotechnology company Celltrion in December 2017. In March 2018 Indian generics maker Lupin Pharmaceuticals (Lupin) made an agreement with the Council of Scientific and Industrial Research-National Chemical Laboratory (CSIR-NCL) and the Department of Science and Technology (DST).
Mylan and Revance team up for botox biosimilar
US-based drugmaker Mylan announced on 28 February 2018 that it had made a deal with Revance Therapeutics to make a biosimilar of Allergan’s cosmetic blockbuster Botox (onabotulinumtoxinA).
MENA region biologicals maker CinnaGen receives EU GMP certification
Iranian biopharmaceutical company, CinnaGen, has been issued a certificate of good manufacturing practice (GMP) compliance by the European Union (EU) at the end of 2017.
Biocon and Sandoz join forces for global next-generation biosimilars
On 18 January 2018, Biocon and Sandoz announced a global partnership to develop, manufacture and commercialize new next-generation biosimilars that will be available worldwide. This collaboration aims to increase global patient access to a range of high quality, affordable immunology and oncology biological medicines.
Top 10 most read GaBI Online articles in 2017
A lot has happened on the subject of biosimilars development in the past year. An important milestone for biosimilars in 2017 was the issuing of guidance on interchangeability by the US Food and Drug Administration (FDA). While the European Medicines Agency (EMA) approvals of insulin and rituximab biosimilars and the FDA’s approval of adalimumab and bevacizumab biosimilars, altogether three biosimilar cancer monoclonal antibodies have been approved in 2017, will benefit more patients worldwide to targeted biological treatments which were expensive to access in the past. Other subjects of interest for biosimilars were FDA’s update of its Purple Book for biologicals and biosimilars, as well as the studies and evolution in interchangeability, switching and substitution of biosimilars.
J&J drops lawsuit against Samsung Bioepis over Remicade biosimilar
Healthcare giant Johnson & Johnson (J&J) has dropped its lawsuit against South Korean biosimilars maker Samsung Bioepis for infringing patents on the company’s blockbuster immunology drug Remicade (infliximab).
Judge denies attempt to dismiss pay-for-delay class action
A federal judge ruled on 3 November 2017 against a motion by three drugmakers to shut down antitrust litigation involving the Lidoderm (lidocaine) pain patch.
Merck KGaA and Samsung BioLogics extend strategic alliance
German drugmaker Merck KGaA (Merck Group) announced on 1 November 2017 that it had signed a ‘Memorandum of Understanding (MoU) with Samsung BioLogics for a strategic alliance on biopharmaceutical manufacturing and biologic[al]s process development’.
Amneal and Impax combine to create 5th largest US generics company
US generics makers Amneal Pharmaceuticals (Amneal) and Impax Laboratories (Impax) announced on 17 October 2017 that they had entered into a definitive deal to combine the two companies.
Synthon prevails over Copaxone patent dispute
On 13 September 2017, the Technical Board of Appeal (TBA) of the European Patent Office (EPO) revoked the patent for Teva Pharmaceutical’s (Teva) synthesis of the active ingredient in Copaxone, a key drug used to treat recurring multiple sclerosis (MS). The case against Israel-based Teva was filed by the Netherlands-based generics and biopharmaceuticals company Synthon BV, who is now clear to market their generic glatiramer acetate in a number of European countries.
Amgen and Simcere to collaborate on copy biologicals in China
Biotech giant Amgen and China-based Simcere Pharmaceutical Group (Simcere) announced on 26 September 2017 that they have made an exclusive agreement to co-develop and commercialize four copy biologicals in China.
Fresenius Kabi acquires Merck KGaA’s biosimilars business
Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 1 September 2017 that it had ‘successfully closed the acquisition of Merck KGaA’s biosimilars business’.
Generics in Greece most expensive in the EU and uptake remain low
Despite being one of Europe’s poorest countries, Greece continues to spend on expensive patented drugs and only a quarter of medicines prescribed in the country are generics, according to recent analysis by Politico.
Daiichi Sankyo ends deal with Coherus for etanercept biosimilar in Japan
Daiichi Sankyo announced on 5 July 2017 that it was ending its co-development in Japan with Coherus BioSciences (Coherus) of a biosimilar to Amgen’s arthritis drug Enbrel (etanercept).
German drugmaker Stada to be sold for over US$5 billion
After months of discussions, German generics firm Stada has announced that it will be sold for US$5.63 billion to private equity firms Bain Capital and Cinven.
Japan’s Sawai to acquire US generics business Upsher-Smith
Sawai Pharmaceutical Company Ltd (Sawai) has signed an agreement to purchase the generics section of US firm Upsher-Smith in an attempt to enter the vast American pharmaceuticals market.
Fresenius Kabi to acquire Akorn and Merck KGaA’s biosimilars business
Fresenius Kabi, one of the independently operated business segments of global healthcare group Fresenius, announced on 24 April 2017 that it had made two deals ‘to strengthen and diversify’ its business.
Samsung BioLogics and Aurobindo investing in biosimilars
Both Samsung and Aurobindo see a bright future for biosimilars. Samsung BioLogics, which is the specialized biotechnology arm of Samsung, raised almost US$2 billion in November 2016 via an initial public offering (IPO) that valued the company at US$7.9 billion. This, according to Robert Wessman, Chairman and CEO at Alvogen, ‘underlines the confidence of the market in biosimilar companies’. Especially when considering that Samsung BioLogics only came into existence in 2011 [1].
Merck KGaA to sell off biosimilars business
Germany’s drugmaker Merck KGaA (Merck Group) is to sell its biosimilars division, according to a statement made in its 2016 annual report.
Australians pay too much for prescription drugs
Australians are paying way too much for their prescription drugs, according to a new report released in March 2017 by the Grattan Institute, an independent, non-partisan think tank.
CinnaGen to invest in Turkish pharmaceuticals sector
Turkey’s health minister, Mehmet Muezzinoglu, has announced that the country is planning to produce medicines locally by attracting foreign investors. The strategy aims to reduce healthcare spending in the country and reduce its reliance on imports of medicines from foreign countries.
Intas enters top 20 generics firms through Actavis purchase
Intas Pharmaceuticals (Intas) has completed a deal to acquire Actavis UK and Actavis Ireland (Actavis UK and Ireland) from Teva Pharmaceutical (Teva) for over GBP 600 million.
Baxter expands injectables portfolio with purchase of Claris Injectables
US-based Baxter International Inc (Baxter) has announced its acquisition of India’s Claris Injectables Ltd, which will enhance the company’s position in the global injectables market.
Mabion signs agreement with Mylan for rituximab biosimilar
Global specialty pharmaceuticals firm Mylan has reached an agreement with Mabion, a leading biotechnology company in Poland, for the exclusive right to commercialize their rituximab biosimilar candidate in the European Union (EU).
