Pharma News

PlantForm and partners in Brazil to develop pembrolizumab biosimilar

Canada-based PlantForm Corporation (PlantForm) have signed an agreement with partners in Brazil to develop a biosimilar of the cancer treatment pembrolizumab (Keytruda).

Biocon partners with Libbs for the sale of generics in Brazil

India-based biologicals specialist Biocon has formed an out-licensing agreement with Brazil-based company Libbs Farmaceutica for the sale of generic drugs in the country, marking Biocon’s entry into the Latin American market for generics.

New partnerships for Cipla and Samsung Bioepis

In March 2021, Cipla announced that its subsidiary, Cipla Gulf is expanding its partnership with Alvotech for the marketing and distribution of four biosimilar medicines in Australia and New Zealand. Samsung Bioepis also announced that it has signed a marketing partnership with Yuhan to launch its biosimilar of Humira (adalimumab), Adalloce, in South Korea.

Pfizer sells Chinese copy biologicals plant to WuXi Biologics

China-based WuXi Biologics announced on 17 March 2021 that it had made an agreement with Pfizer China to acquire its state-of-the-art biologicals manufacturing facilities as well as its labour force in Hangzhou, China.

Sandoz acquires GSK antibiotics and Perrigo generics sold to Altaris

In February 2021, Sandoz signed an agreement to acquire GSK’s cephalosporin antibiotics business. In March 2021, Perrigo Company sold their generic drug business to private investment firm, Altaris Capital Partners LLC. 

Biocon Biologics partners to improve global access to cancer treatments and insulin

In February 2021, Biocon Biologics joined forces with international organizations to improve access to cancer and diabetes treatments. The India-based biological subsidiary of Biocon, entered into an agreement with the Clinton Health Access Initiative (CHAI) to expand access to cancer biosimilars in over 30 countries in Africa and Asia as a part of the Cancer Access Partnership (CAP) [1]. In addition, they have become the first biosimilar insulin company to partner with the International Diabetes Federation (IDF) to promote and support the latter’s initiatives [2].

Korean biosimilars makers pipelines and expansion

Korean biosimilars makers have started conducting global clinical trials and are expanding into other markets with their biosimilars.

Innovent makes deal for bevacizumab copy biological in Indonesia

China-based Innovent Biologics (Innovent) announced on 19 January 2021 that it had made an agreement with PT Etana Biotechnologies Indonesia (Etana) to out-license the development and commercialization rights for its bevacizumab copy biological, Byvasda, in Indonesia to Etana.

Partnerships formed and extended between Isu Abxis/Pharmasyntez and Alvotech/Fuji Pharma

The South Korean company Isu Abxis will export technology for a rare blood disease treatment, a biosimilar of Soliris, to the Russian firm Pharmasyntez.

Top 10 most read GaBI Online articles in 2020

This article reviews some of the most important events for biosimilars during 2020. For biosimilars these included the World Health Organization’s (WHO) prequalification of its first biosimilar and US Food and Drug Administration (FDA) rules and guidance. Other subjects of interest for biosimilars were European Medicines Agency (EMA) approvals, the biosimilars market in Latin America, biosimilar litigation, and extrapolation, immunogenicity, switching and substitution of biosimilars.

Celltrion: Takeda acquisitions and new plant development

Celltrion completed the acquisition of selected primary care assets from Takeda Pharmaceutical Company Limited in the Asia Pacific region in November 2020. In addition, the company announced it will be building a new biopharmaceutical plant and a global biotechnology research centre in Songdo, Incheon, South Korea.

Momenta to reduce its biosimilars programmes

US-based biotechnology firm Momenta Pharmaceuticals (Momenta) announced on 1 October 2018 that it would be focusing on two key biosimilars and quit the development of five others.

New Alvotech partnerships in South Africa and China

Iceland-based biopharmaceutical company Alvotech entered into two partnerships in November 2020, that will expand their reach into South Africa and China.

AffaMed and EverInsight merger announced

AffaMed Therapeutics announced a merger agreement with EverInsight Therapeutics on 10 October 2020.  

Essex and Henlius collaborate to deliver bevacizumab biosimilar for ophthalmic diseases

On 15 October 2020, it was announced that two Essex Bio-Technology subsidiaries were entering an agreement with Shanghai Henlius Biotech. Under this, Essex Bio-Investment and Zhuhai Essex Bio-Pharmaceuticals will work with Henlius to co-develop a bevacizumab biosimilar for the treatment of ophthalmic diseases. 

Medicure and Reliance sign cardiovascular drug agreement

Medicure Inc announced on 5 October 2020 that it has entered a License, Manufacture and Supply Agreement with Reliance Life Sciences Private Limited (RLS) for a cardiovascular drug. Under this agreement, Medicure is responsible for the regulatory approval process for the drug product and is granted the exclusive right to market and sell it in Canada, European Union and the US. The cardiovascular drug is currently unnamed. 

Aurobindo and Huons refocus their biologicals/biosimilars portfolios

India-based generics maker Aurobindo Pharma (Aurobindo) has announced a renewed product focus and plans for the biosimilars of its subsidiary company. In addition, Korea-based Huons will collaborate with Singapore-based Prestige BioPharma’s (Prestige) to enter the biosimilars market.

Lotus to distribute CKD’s biosimilar darbepoetin alfa in South East Asia

On 18 September 2020, Taiwan-based Lotus Pharmaceutical Co (Lotus) announced a long-term collaboration with Korea-based Chong Kun Dang Pharmaceutical Corp (CKD) for the distribution of biosimilar darbepoetin alfa (CKD-1110) in South East Asia.

Henlius and Accord collaborations will see their trastuzumab biosimilar launch globally

On 30 September 2020, Accord Healthcare (Accord) and Shanghai Henlius Biotech announced that they are to enter a new collaboration. As part of their agreement, Henlius will grant an exclusive licence to Accord US to develop and commercialize their trastuzumab biosimilar in Canada and the US. This follows the June 2018 Henlius‒Accord UK licence agreement, under which Henlius granted Accord UK exclusive commercialization rights of HLX02 trastuzumab. This led the product being approved by the European Commission in July 2020 [1] and its UK launch on 24 September 2020. 

Mylan-Upjohn merger receives go ahead from Europe, Australia and New Zealand

The proposed merger between Mylan and Pfizer’s Upjohn receives the go-ahead from authorities in Europe, Australia and New Zealand. The agreement to combine the two companies was finalised on 29 July 2020. However, the transaction was held-up due to the COVID-19 pandemic and is now likely to close in the later part of 2020.

Bio-Thera and BeiGene sign deal to license, distribute and supply Avastin copy biological BAT1706 in China

On 24 August 2020, China-based pharmaceutical companies Bio-Thera Solutions (Bio-Thera) and BeiGene announced that they have entered into a license, distribution and supply agreement for BAT1706, an investigational copy biological to Avastin^® (bevacizumab), in China. 

Ligand to acquire biosimilars manufacturer Pfenex

Ligand Pharmaceuticals Incorporated (Ligand) is to acquire Pfenex Inc (Pfenex), a manufacturer of biosimilars including teriparatide, ranibizumab and pegfilgrastim.

Kodak Pharmaceutical deal under scrutiny

In late July 2020, US President Donald Trump announced that the Federal Government would be loaning Eastman Kodak Co US$765 million to develop generic drugs. This is the first loan to be granted under the US Defense Production Act that was passed in response to the global COVID-19 pandemic. Now, amid allegations of insider trading, the House of Representatives will review the Kodak Pharmaceutical deal and there will be a Securities and Exchange Commission (SEC) investigation.

Bio-Thera partners with Pharmapark to market golimumab biosimilar in Russia and other CIS countries

China-based biopharmaceutical company Bio-Thera Solutions (Bio-Thera) announced on 18 July 2020 that it has signed a licensing agreement for its proposed golimumab biosimilar BAT2506 with Russia-based Pharmapark.

Teva changes course in Japan and the US

Israeli drugs manufacturer Teva has made strategic decisions in the US and Japan. The company plans to strip back its Japanese venture with Takeda, selling off parts of the portfolio by early 2021. However, in the US, Teva will be entering a strategic partnership with Alvotech for the commercialization of five biosimilar candidates. 

Perrigo sells its UK generic drug business

Perrigo Co Plc (Perrigo) has sold its generic prescription drug business to a private equity firm in a deal worth US$195 million.

COVID-19 drug trials underway

There are over 200 trials for COVID-19 currently in progress. These include trials of monoclonal antibodies, including from the South Korean firm Celltrion, as well as vaccines, notably from the Chinese firm CanSino Biologics.

Aurobindo/Sandoz deal falls through, biosimilars business transferred to subsidiary

It has been announced that Aurobindo Pharma’s planned deal to take over the US generic oral solids and dermatology businesses of Sandoz has fallen through. More recently, the company has transferred its biosimilars business to its wholly owned subsidiary CuraTeQ Biologics.

Fresenius Kabi signs marketing agreement for adalimumab biosimilar

German pharmaceutical company Fresenius Kabi has signed an agreement with methotrexate supplier Medac for the sale of its adalimumab biosimilar Idacio. The agreement is likely to boost sales of Idacio.

Success for Celltrion in Japan and Samsung Bioepis in Europe

South Korean biosimilar manufacturer Celltrion’s trastuzumab biosimilar has gained a 40% market share in Japan. Meanwhile, Samsung Bioepis, which is also headquartered in South Korea, announced European sales in excess of US$200 million in the first quarter of 2020.

Canadian firm Bausch + Lomb signs agreement on Lucentis biosimilar

Canadian eye health specialists Bausch + Lomb have signed an exclusive licensing agreement with Stada and its development partner Xbrane to develop and commercialize a Lucentis biosimilar in Canada and the US.

Mycenax sells tocilizumab biosimilar to Richter

Taiwanese biosimilars developer Mycenax announced on 28 April 2020 that it had made a deal with Hungary-based Gedeon Richter (Richter) regarding its tocilizumab biosimilar.

Dr Reddy’s buys Wockhardt plant and Strides acquires 18 ANDAs

Dr Reddy’s Laboratories (Dr Reddy’s) is to acquire US$260 million worth of Wockhardt’s business including a major manufacturing facility in India, while Strides is to acquire 18 abbreviated new drug applications (ANDAs) for the US market.

FDA’s response to coronavirus

In response to the coronavirus pandemic, the US Food and Drug Administration (FDA) has issued a comprehensive statement regarding effects on the supply chain and inspections of plants overseas.

Roche continues litigation in India and receives fine in Romania

Switzerland-based pharmaceutical giant Roche is continuing to pursue legal action in India over a trastuzumab similar biologic and has recently been fined in Romania for delaying the entry of biosimilars to the market.

New biosimilars partnerships from Alvotech and Biocon

Alvotech has formed an exclusive partnership with JAMP Pharma (JAMP) for the commercialization of its biosimilars in Canada, while Biocon has expanded its collaboration with Equillium to include Australia and New Zealand.

Amgen to buy out Japanese partner Astellas

US-based biotech giant Amgen has announced that it will dissolve its joint venture with the Japanese company Astellas in order to operate the unit independently. This means Astellas will become a wholly-owned Amgen affiliate.

Celltrion to build facility in China and increase new drug output

South Korean biotechnology company Celltrion has announced plans to build its first overseas factory in China. The company also intends to release one new biosimilar per year until 2030.

Merck to create spin off for women’s health and biosimilars

US pharma giant Merck is to create a spin-off company for its women’s health, biosimilars and legacy products, allowing the main company to focus on blockbuster cancer drug Keytruda (pembrolizumab).

US health insurers partner with generics maker Civica

The Blue Cross Blue Shield Association (BCBSA), a federation of health insurers in the US, has formed a partnership with generics manufacturer Civica Rx to reduce the costs of generic drugs.

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].