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.
