Biosimilars are the key alternatives for expensive Biologics therapies and saving millions of dollars of patients spent in the treatment of multiple diseases. Hence physicians are likely to adopt biosimilars a reference product to biologics possessing similar therapeutic properties in terms of potency- safety- and efficacy to original biologic products. The companies are focusing on the expansion of their pipeline and portfolio in Biosimilars. In 2018- Amgen collaborated with Orion for the commercialization of Amgevita (biosimilar- adalimumab) in Finland in addition to STADA’s joint development agreement with Xbrane Biopharma for Xlucane (biosimilar- ranibizumab). Biocon also came up with CHMP recommendations for its biosimilars Fulphila (biosimilar- pegfilgrastim) and Ogivri (biosimilar- trastuzumab) targeted to treat Neutropenia and HER-2 Breast Cancer respectively. Our team at PharmaShots has compiled a list of top biosimilar companies developing and marketing biosimilars in the EU and the US arranged in alphabetical orders.
Amgen
Total Biosimilar Products: 9 Biosimilar Pipeline Products: 4
Founded Year: 1980 Headquarter: United States
Market Cap: $139.36B Stock Exchange: NASDAQ
Amgen is one of the leading biotechnology company developing novel therapies focused on Cardiology- Oncology- Immunology- Neurology- Nephrology- and Inflammatory diseases. In Oct 2018 Amgen signed an agreement with Orion for the commercialization of Amgevita (adalimumab- biosimilar) in Finland. Additionally- in H2’18 Amgen also launched its first inflammation biosimilar Amgevita (biosimilar- adalimumab) in Europe for the treatment of inflammatory diseases including all possible indications for Humira (adalimumab). Amgen’s ABP 710 (biosimilar infliximab) reported results of P-III study in comparison with Remicade (infliximab) for patients with moderate-to-severe rheumatoid arthritis with its BLA submitted to the FDA. Amgen’s ABP 798 (biosimilar- rituximab) has completed its P-III studies for moderate to severe RA & NHL and the trial evaluating ABP 959 (biosimilar- eculizumab) is recruiting patients for P-III for Paroxysmal nocturnal hemoglobinuria (PNH).
Apotex/Apobiologix
Total Biosimilar Products: 5 Biosimilar Pipeline Products: 5
Founded Year: 1974 Headquarter: Canada
Market Cap: NA Stock Exchange: NA
Apotex is a generics drugs company- headquartered in Canada. Apobiologix is a member of the Apotex Group of Companies- focused on the development of biosimilars. Apobiologix has launched its pegfilgrastim biosimilar- Lapelga- in Canada in Q1’19. Apobiologix has been developing 5 products for the US market- including Epoetin alfa- Darbepoetin alfa- Bevacizumab- Rituximab- and Trastuzumab.
Biocon
Total Biosimilar Products: 5 Biosimilar Pipeline Products: 4
Founded Year: 1978 Headquarter: India
Market Cap: ~$4.29B Stock Exchange: NSE
Biocon is a global pharmaceutical company involved in discovering- developing and producing therapies in chronic therapies such as Diabetes- Oncology- and Immunology. The vast portfolio of Biocon can be further divided into APIs and Generic formulations- Biologics & Biosimilars and Branded Formulations. In Sept 2018- Biocon and Mylan’s Fulphila (biosimilar- pegfilgrastim) received CHMP recommendation for neutropenia. Biocon’s Insulin Aspart and Krabeva (biosimilar- bevacizumab) are targeted for diabetes and multiple indications in cancer respectively while they are currently being evaluated in P-III study.
Biogen
Total Biosimilar Products: 3 Biosimilar Pipeline Products: 2
Founded Year: 1978 Headquarter: United States
Market Cap: ~$54.74B Stock Exchange: NASDAQ
Biogen is a US-based biotech company focused on the development of therapies in neuroscience particularly in multiple sclerosis and neuroimmunology- neuromuscular disorders- movement disorders- ophthalmology- immunology- neurocognitive disorders- acute neurology- and pain. In 2018- the company also reported pooled results of P-III studies for Benepali (biosimilar- etanercept)- Flixabi (biosimilar- infliximab)- and Imraldi (biosimilar- adalimumab) in patients with moderate to severe rheumatoid arthritis. In 2019- Biogen signed an agreement with Samsung Bioepis to acquire exclusive commercialization rights for SB11 (biosimilar- ranibizumab) in the US- EU- Japan- Australia and Canada including Benepali- Flixabitm- and Imraldi in China.
Boehringer Ingelheim
Total Biosimilar Products: 15 Biosimilar Pipeline Products: 12
Founded Year: 1885 Headquarter: Germany
Market Cap: N/A Stock Exchange: N/A
Boehringer Ingelheim is a Germany based global pharmaceutical company focused on developing therapies for multiple therapy areas including Cardiovascular- Oncology- CNS- Respiratory- Immunology- Metabolic diseases- and Retinal Health. In 2018- BI reported P-III results of Cyltezo (biosimilar- adalimumab) in patients with moderate-to-severe plaque psoriasis. Additionally- BI has BI 695502 (biosimilar- bevacizumab) in P-III targeted for the treatment of patients with advanced non-squamous NSCLC.
Celltrion
Total Biosimilar Products: 6 Biosimilar Pipeline Products: 1
Founded Year: 2002 Headquarter: South Korea
Market Cap: $20.189B Stock Exchange: KRX
Celltrion is a Korea based healthcare company offering development and sales of the biosimilar in fields of Autoimmune Disorders and Oncology. In Dec 2018 Celltrion’s CT-P10 (biosimilar- rituximab) showed well-tolerated and safe results in P-III in patients with advanced follicular lymphoma (AFL). In 2018- Celltrion and Teva’s Herzuma (CT-P6- biosimilar- trastuzumab) and Truxima (rituximab-abbs) also received the FDA’s approval for HER2-overexpressing breast cancer and three NHL indications respectively. Additionally- Celltrion’s CT-P16 (biosimilar- bevacizumab) is also evaluated in P-III trial for treating Colorectal Cancer.
Coherus Biosciences
Total Biosimilar Products: 4 Biosimilar Pipeline Products: 3
Founded Year: 2010 Headquarter: United States
Market Cap: ~$1.35B Stock Exchange: NASDAQ
Coherus is a leading biosimilar company focused on developing candidates in multiple therapeutic areas including oncology- immunology- and ophthalmology. In 2018- Coherus Udenyca (biosimilar- pegfilgrastim) received the EU’s MAA and the US FDA’s approval for febrile neutropenia and patients receiving myelosuppressive chemotherapy respectively. Coherus’ two biosimilars CHS-1420 (biosimilar- adalimumab) and CHS-0214 (biosimilar- etanercept) have also completed their P-III studies for psoriasis and RA respectively.
Fresenius Kabi
Total Biosimilar Products: 6 Biosimilar Pipeline Products: 4
Founded Year: 1999 Headquarter: Germany
Market Cap: N/A Stock Exchange: N/A
Fresenius Kabi is a global healthcare company with a portfolio of IV generic drugs- infusion therapies- and clinical nutrition products including devices for administration of these drugs and biosimilars focusing on Oncology and autoimmune disorders. In 2018- the company signed a settlement and license agreement with AbbVie for its all pending patent litigations regarding the commercialization of Fresenius MSB11022 (biosimilar- adalimumab) in the US. In late 2018- Fresenius also released the results of its MSB11455 (biosimilar- pegfilgrastim) meeting all 1EPs.
Fujifilm Kyowa Kirin Biologics
Total Biosimilar Products: 3 Biosimilar Pipeline Products: 2
Founded Year: 1934 Headquarter: Japan
Market Cap: ~$24.4B Stock Exchange: TYO
Fujifilm Kyowa Kirin Biologics is a Japan-based biopharmaceutical company focused on developing biosimilars targeting Immunology & Oncology. The company leverages Kyowa Kirin’s R&D and production expertise- manufacturing- quality management- and analytical skills along with Fujifilm wide-ranging business to create an innovative production process leading to a reduction in production cost.- In 2018- Kyowa Kirin and Mylan collaborated to commercialize Hulio (FKB327) (biosimilar- adalimumab) and has also received EMA’s marketing authorization for Rheumatoid Arthritis- Psoriasis- Crohn’s Disease.
Gedeon Richter
Total Biosimilar Products: 2 Biosimilar Pipeline Products: 2
Founded Year: 1901 Headquarter: Hungary
Market Cap: 3.174B Stock Exchange: Budapest Stock Exchange
Gedeon Richter is a Budapest based company- focused on developing therapies for multiple therapeutic areas including Women’s Healthcare- Central Nervous System- and Cardiovascular areas. In early 2018- EMA initiated the evaluation of Richter’s resubmitted marketing authorization application for proposed biosimilar pegfilgrastim. In 2018- Richter acquired IPR for Bemfola for use in the US.
Intas/Accord Healthcare
Total Biosimilar Products: 6 Biosimilar Pipeline Products: 6
Founded Year: 1968 Headquarter: Ahmedabad- India
Market Cap: NA Stock Exchange: NA
Intas is a pharmaceutical company focused on developing therapies for CNS- CVS- Oncology- Diabetes- Gastroenterology- Pain Management- Urology- Nephrology- Gynecology- Infertility- and Respiratory Care. Intas biosimilars are developed at the company’s European Union-Good Manufacturing Practices (EU-GMP) certified biotechnology plant situated near Ahmedabad.
Mabion
Total Biosimilar Products: 3 Biosimilar Pipeline Products: 3
Founded Year: 2007 Headquarter: Poland
Market Cap: ~$1.34B Stock Exchange: WSE
Mabion is a Poland based leading biopharmaceutical company developing and commercializing biosimilar and drugs based on its monoclonal antibody technology. In 2018- Mabion filed marketing authorization for its Mabion CD20 (biosimilar- rituximab) candidate- targeted to treat RA patients and patients with non-Hodgkin’s lymphoma.
Merck & Co.
Total Biosimilar Products: 3 Biosimilar Pipeline Products: 0
Founded Year: 1894 Headquarter: United States
Market Cap: ~$222.37B Stock Exchange: NYSE
Merck is a global healthcare leader focused on developing- discovering and providing prescription medicines- vaccines- biologic therapies- and animal health products. In 2018- Merck Renflexis (biosimilar- infliximab) determined to be of the lowest-priced infliximab option available and was also awarded a national contract by the VA. With the approval- in 2018 Merck also terminated its deal with Samsung Bioepis for Lusduna (biosimilar- insulin glargine) and paid $155M as a termination fee.
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