Top Biosimilar Companies with Approved and Pipeline Products in the US and EU

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.

Mundipharma

Total Biosimilar Products: 4                                                      Biosimilar Pipeline Products: 0

Founded Year: 1952                                                                       Headquarter: Poland

Market Cap: NA                                                                               Stock Exchange: NA

Mundipharma is a leading healthcare company involved in developing therapies for Diabetes, Respiratory, Oncology and Pain Management. In 2018, Mundipharma acquired Pelmeg from Cinfa Biotech and in Nov 2018, Mundipharma’s Pelmeg (biosimilar, pegfilgrastim) received the European Union’s approval. Additionally, in late 2018, the company acquired Cinfa Biotech to expand its biosimilar portfolio.

Mylan  

Total Biosimilar Products: 7                                                          Biosimilar Pipeline Products: 4

Founded Year: 1961                                                                          Headquarter: Netherlands

Market Cap: ~$8.89B                                                                        Stock Exchange: NASDAQ 

Mylan is a global pharmaceutical company having a divested portfolio including 20 biosimilars and insulin analogs products targeted for Oncology, Immunology, Endocrinology, and Ophthalmology. In 2018, Mylan and Biocon received CHMP recommendation for its Ogivri (biosimilar, trastuzumab) for the treatment of HER-2 Breast Cancer. Additionally, in late 2018, Mylan launched its Hulio (biosimilar, adalimumab) for Autoimmune Disorders in Europe. 

Pfizer

Total Biosimilar Products: 7                                                      Biosimilar Pipeline Products: 1

Founded Year: 1849                                                                      Headquarter: United States

Market Cap: ~$205.98B                                                               Stock Exchange: NYSE

Pfizer is a biopharma company involved in developing drugs and biosimilars in therapy areas of Oncology, Inflammation & Immunology, Rare Disease, Hospital, Vaccines, and Internal Medicine. In 2018, Pfizer received the US FDA’s approval for its Nivestym (biosimilar, filgrastim) for all eligible indications of the reference product. Additionally, in late 2018, Pfizer received CHMP’s positive opinion for its Zirabev (biosimilar, bevacizumab). Pfizer also reported updated top-line positive results of PF-05280586 (biosimilar, rituximab) vs MabThera in 1L patients with CD20-positive, low tumor burden, follicular lymphoma.

Samsung Bioepis

Total Biosimilar Products: 9                                                          Biosimilar Pipeline Products: 5

Founded Year: 2012                                                                          Headquarter: South Korea

Market Cap: N/A                                                                                 Stock Exchange: N/A

Samsung Bioepis is a Korean biopharmaceutical company focused on the advancement of its biosimilar pipeline in multiple therapeutic areas including Immunology, Oncology, Ophthalmology, and Hematology. In 2018, the US FDA accepted Samsung Bioepis’ Imraldi (SB5, biosimilar, adalimumab) BLA for review and is also approved in the EU, Korea, Australia, and Canada. The company has a total of 4 approved biosimilars out of 7 biosimilars including 3 for immunology, 2 for oncology, while the rest in ophthalmology and hematology.

Sandoz

Total Biosimilar Products: 10                                                     Biosimilar Pipeline Products: 2

Founded Year: 2003                                                                        Headquarter: Germany

Market Cap: N/A                                                                               Stock Exchange: N/A

Sandoz, a Novartis division is a global leader in developing, manufacturing and marketing of Retail Generics, Anti-Infectives, and Biopharmaceuticals for Cardiovascular, CNS, Dermatology, Gastrointestinal & Hormonal disorders, Metabolism, Oncology, Ophthalmic pain, and Respiratory disorders. In 2018, Sandoz collaborated with Biocon to develop, manufacture and commercialize multiple biosimilars in Immunology and Oncology. Additionally, the company launched three biosimilars Hyrimoz (biosimilar, adalimumab), Zessly (biosimilar, infliximab) and Ziextenzo (biosimilar, pegfilgrastim) in EU for inflammatory disease, immunological disease, and Neutropenia respectively in 2018. The company has LA-EP2006 (pegfilgrastim) and GP2411 (denosumab) as P-III candidates in their pipeline.

STADA Arzneimittel  

Total Biosimilar Products: 2                                                         Biosimilar Pipeline Products: 14

Founded Year: 1895                                                                          Headquarter: Germany  

Market Cap: ~$B                                                                                Stock Exchange: Xetra

STADA is an international pharmaceutical company and is divided into three segments generics, non-prescription OTC products, and biosimilars focused on developing therapies for oncology, the central nervous system (CNS), diabetes and ophthalmology. STADA has two marketed biosimilars in its portfolio Silapo, (biosimilar, erythropoietin) and Grastofil (biosimilar, filgrastim). Additionally, in Jul 2018, the company signed a joint development agreement with Xbrane Biopharma for Xlucane (biosimilar, ranibizumab). Additionally, in 2018 EMA accepted the resubmitted MAA for proposed biosimilar pegfilgrastim.

Teva

Total Biosimilar Products: 4                                                       Biosimilar Pipeline Products: 2

Founded Year: 1944                                                                        Headquarter: Israel

Market Cap: ~$11.30B                                                                    Stock Exchange: NYSE

Teva is a leading pharmaceutical company developing and producing Generics, Specialty, OTC and API for multiple therapeutic areas including CNS, Oncology, and Respiratory. In 2018, Celltrion and Teva’s Herzuma (biosimilar, trastuzumab) received the US FDA’s approval for the treatment of HER2-overexpressing breast cancer for certain indications. Additionally, in 2018, Truxima (biosimilar, rituximab) also received the US FDA’s approval for three Non-Hodgkin’s Lymphoma indications.