Pharma News

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].

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’.