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Variant of a biopharmaceutical
A biosimilar (also known as follow-on biologic or subsequent entry biologic) is a biologic medical product that is almost an identical copy of an original
Biosimilar
Monoclonal antibody pharmaceutical drug
Health Organization's List of Essential Medicines. It is available as a biosimilar medication. In 2023, it was the 244th most commonly prescribed medication
Adalimumab
Modified forms of synthetic insulin
with the biosimilar market valued at $8.8 billion. The global human insulin market was valued at $22.9 billion in 2020, while the biosimilar insulin market
Insulin_analogue
Drug made from biological source
follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals
Biopharmaceutical
Pharmaceutical drug
2024. It is a biosimilar to Eylea. In August 2024, aflibercept-abzv (Enzeevu) was approved for medical use in the US. It is a biosimilar to Eylea. In August
Aflibercept
Biopharmaceutical drug for autoimmune disorders
States in 1998, and in the European Union in August 1999. Infliximab biosimilars have been approved in the EU (2013), in Japan (2014), and in the United
Infliximab
Pharmaceutical drug for treating osteoporosis
Teva Generics has been authorized for marketing in the European Union. Biosimilar product from Gedeon Richter plc has been authorized in the European Union
Teriparatide
Swiss pharmaceuticals and biosimilars company
Group AG is a Swiss company that focuses on generic pharmaceuticals and biosimilars. Prior to October 2023, it was part of a division of Novartis that was
Sandoz
Human monoclonal antibody
Denosumab, sold under the trade name Prolia among others, as well as many biosimilars, is a human monoclonal antibody used for the treatment of osteoporosis
Denosumab
Indian multinational biopharmaceutical company
novel biologics as well as biosimilar insulins and antibodies, which are sold in India as branded formulations. Biocon's biosimilar products are also sold
Biocon
Medication
the World Health Organization's List of Essential Medicines. Filgrastim biosimilar medications are available. Filgrastim is used to treat neutropenia; acute
Filgrastim
Long-acting insulin
the US Food and Drug Administration (FDA) approved an interchangeable biosimilar insulin product called Semglee (insulin glargine-yfgn) for the treatment
Insulin_glargine
Type of arthritis of the spine
context of ankylosing spondylitis, biosimilars are typically used as alternatives to the original biologic drugs. Biosimilars for ankylosing spondylitis may
Ankylosing_spondylitis
American publicly traded generics and specialty pharmaceutical company
the biosimilar space has included a 2017 partnership with Adello Biologics (for the collaborative development of Neupogen and Neuasta biosimilars) and
Amneal_Pharmaceuticals
Rapid-acting man-made insulin
Solostar, is a biosimilar to Novolog that was approved for medical use in the United States in February 2025. It is the first biosimilar to Novolog approved
Insulin_aspart
Biopharmaceutical drug
applicant for this medicinal product is STADA Arzneimittel AG. Uzpruvo is a biosimilar medicinal product. Uzpruvo was authorized for medical use in the European
Ustekinumab
Medication
clinical data demonstrating that Herzuma is biosimilar to US Herceptin. Herzuma has been approved as a biosimilar, not as an interchangeable product. Kanjinti
Trastuzumab
developing biosimilars for global markets, including the US and EU. Arven has obtained a marketing authorization in 2016 for the biosimilar of Filgrastim
Arven_Pharmaceuticals
Biopharmaceutical for autoimmune diseases
Act of 2009) do have in place a system to approve generic biologics (biosimilars) which "requires mandatory clinical testing and periodic review". In
Etanercept
Biopharmaceutical drug
Rituximab Patent". Center for Biosimilars. Retrieved 27 July 2024. "Biosimilars of Rituximab". Generics and Biosimilars Initiative. 14 April 2017. Archived
Rituximab
South Korean biopharmaceutical company
"EMA Approves First MAb Biosimilars". BioPharma-reporter.com. "Biosimilar trastuzumab approved in Korea". Generics and Biosimilars Initiative. 17 January
Celltrion
Indian multinational pharmaceutical company
Pharma launches biosimilar in Europe". The Hindu. ISSN 0971-751X. Retrieved 3 October 2021. "Intas Pharmaceuticals launches biosimilar in Europe". The
Intas_Pharmaceuticals
Medication
system for biosimilars". BioPharma-Reporter. Archived from the original on 10 January 2016. Retrieved 18 March 2020. "FDA approves first biosimilar for the
Bevacizumab
South Korean pharmaceutical company
revenues, and has attracted attention for its development of an aflibercept biosimilar (SCD411) and an oral semaglutide generic. Sam Chun Dang Pharm was established
Sam_Chun_Dang_Pharm
Canadian pharmaceutical company
months' supply of the generic drug." In 2013, Apotex began selling a biosimilar version of Amgen's Neulasta in Europe, a blockbuster drug used by cancer
Apotex
Group of countries not in major power blocs
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Non-Aligned_Movement
Pharmaceutical equivalent to a brand-name product
monoclonal antibodies, differ biologically from small-molecule drugs. Biosimilars have active pharmaceutical ingredients that are almost identical to the
Generic_drug
Piece of American regulatory legislation
to biosimilar biological products: (1) biosimilar program development fees, encompassing an initial biosimilar development fee, an annual biosimilar development
Food and Drug Administration Safety and Innovation Act
Food_and_Drug_Administration_Safety_and_Innovation_Act
that facilitate timely access to lower-cost, FDA-approved generic and biosimilar medicines by consumers and patients. Over the 10-year period 2008 through
Association for Accessible Medicines
Association_for_Accessible_Medicines
South Korean multinational conglomerate
(Massachusetts) (BIIB) Teams With Samsung Corporation on $300 Million Biosimilar Venture (Press release), BioSpace, biospace.com, archived from the original
Samsung
American pharmaceutical and healthcare corporation
the company became a member of the Biosimilars Forum, a trade organization that advocates for greater biosimilar usage. Viatris partnered with the American
Viatris
Swiss multinational pharmaceutical corporation
generic drug company. [citation needed] Sandoz' biosimilars lead its field, getting the first biosimilar approvals in the EU. In 2018, Sandoz reported US$9
Novartis
Formulary by the World Health Organization
alternatives, including quality-assured biosimilars Nivolumab is an alternative, including quality-assured biosimilars Enzalutamide is an alternative Alternatives
WHO Model List of Essential Medicines
WHO_Model_List_of_Essential_Medicines
active pharmaceutical ingredients (APIs), formulations, biologics and biosimilars, and vaccines. Various types of companies are within these segments.
Pharmaceutical industry in India
Pharmaceutical_industry_in_India
Atypical antipsychotic medication
customer. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Quetiapine
Immunosuppressive drug
the first tocilizumab biosimilar authorized for medical use in the European Union, and in March 2024, became the first biosimilar with both intravenous
Tocilizumab
Iran-based biotechnology company
founded in 1994 by Hamid Mobtaker.[specify] As of 2016, it manufactured biosimilar drugs, laboratory diagnostic reagents for in vitro use, and recombinant
Cinnagen
Pharmaceutical drug
September 2021. In India, Lupin Limited received marketing approval for its biosimilar of Ranibizumab. In June 2022, the Committee for Medicinal Products for
Ranibizumab
American multinational biopharmaceutical company
Amgen's Trastuzumab Biosimilar, Kanjinti". The Center For Biosimilars. June 13, 2019. "FDA approves Avsola, fourth Remicade biosimilar". www.healio.com.
Amgen
South Korean biotechnology company
with Pfizer for the commercial manufacturing of Pfizer’s multi-product biosimilars portfolio in a deal worth $411 million. A month later, Samsung Biologics
Samsung_Biologics
Indian multinational pharmaceutical company
Ltda. In 2014, Cadila Healthcare launched the world's first adalimumab biosimilar under the brand name Exemptia at one-fifth the originator's price. Zydus
Zydus_Lifesciences
Pharmaceutical drug
December 2018 it was incorporated in the public health care system. A biosimilar branded Elizaria is available in Russia. In February 2023, the Committee
Eculizumab
American pharmaceutical company
Biosimilars provide treatment for oncology and immunology at potentially lower cost than other FDA approved treatments. Organon makes the biosimilar Hadlima
Organon_&_Co.
American pharmaceutical company
the treatment of severe plaque psoriasis. The company also produces 5 biosimilars (8.2% of 2024 revenues) and has collaborations with Genentech for several
Biogen
American multinational pharmaceutical company
Janssen Biotech had rights in other areas; in 2017, Merck announced a biosimilar to Remicade, Renflexis. Januvia (sitagliptin) ($1.3 billion in 2024 revenues)
Merck_&_Co.
Hungarian pharmaceutical company
cardiovascular therapeutic areas among others. The company is also active in biosimilar product development. The company was established in Budapest by Gedeon
Gedeon_Richter_(company)
Monoclonal antibody
applicant for this medicinal product is Biosimilar Collaborations Ireland Limited. Vivlipeg is a biosimilar medicinal product that is highly similar
Pegfilgrastim
Indian pharmaceutical company
of anti-retroviral drugs. Hetero's business includes APIs, generics, biosimilars, custom pharmaceutical services, and branded generics. Hetero Group employs
Hetero_Drugs
Medical treatment
risk of side effects. A lot of research is being done in fields like biosimilars and oral delivery to address these concerns. The use of antibodies to
Biological therapy for inflammatory bowel disease
Biological_therapy_for_inflammatory_bowel_disease
Anti-hypertension medication
inhibitor. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Hydralazine
Anticoagulant medication
Kaszkin-Bettag M (2013). "Safety and toxicity of biosimilars—EU versus US regulation". Generics and Biosimilars Initiative Journal. 2 (3): 144–150. doi:10.5639/gabij
Low-molecular-weight_heparin
Antibiotic medication
2015. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". TGA. Therapeutic Goods Administration. 26 March 2018
Cefuroxime
FDA identifier in the Global Substance Registration System
different protein substances can share the same UNII and yet have no biosimilarity or therapeutic equivalence. Polymers are defined by their structural
Unique_Ingredient_Identifier
Terms that denote two groups of countries
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Global_North_and_Global_South
Type of medication
Gonadotropin preparations are drugs that mimic the physiological effects of gonadotropins, used therapeutically mainly as fertility medication for ovarian
Gonadotropin_preparations
Indian multinational pharmaceutical company
its product portfolio with high-value products in oncology, hormones, biosimilars, and novel drug delivery solutions like depot injections, inhalers, patches
Aurobindo_Pharma
Indian multinational pharmaceutical company
Under Glenn Saldanha, the company focused on developing new drugs and biosimilars in the fields of cancer, dermatology and respiratory diseases, which
Glenmark_Pharmaceuticals
Coalition of developing countries
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Group_of_77
Protein that stimulates red blood cell production
Erythropoietin (/ɪˌrɪθroʊˈpɔɪ.ɪtɪn, -rə-, -pɔɪˈɛtɪn, -ˈiːtɪn/; EPO), also known as erythropoetin, haematopoietin, or haemopoietin, is a glycoprotein cytokine
Erythropoietin
Biotechnology industry in India
biologics and biosimilars. One of Biocon's subsidiaries, Biocon Biologics, manufactures biosimilars. Intas Pharmaceuticals also manufactures biosimilars. Dr. Reddy's
Biotechnology_in_India
Indian businessperson and author
The company specializes in diabetic and cardiovascular drugs as well as biosimilar drugs, injectables and active pharmaceutical ingredients. Leena was born
Leena_Tewari
Cold War ideology promoting the interests of non-aligned countries
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Third-worldism
Medication used to treat multiple sclerosis and Crohn's disease
multiple sclerosis biosimilar". PMLive. 24 July 2023. Archived from the original on 24 July 2023. Retrieved 24 July 2023. "Biosimilar Drug Information"
Natalizumab
Chemical compound
orally. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Dorzolamide
Application process for US generic drug approval
Administration in the United States. It is designed for complex generic or biosimilar medications that can share historical public data from a drug that has
505(b)(2)_regulatory_pathway
create an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product
Biologics Price Competition and Innovation Act of 2009
Biologics_Price_Competition_and_Innovation_Act_of_2009
Icelandic business executive
life. Since 1999, Wessman's career has been focused on the generics and biosimilars sectors of the pharmaceuticals industry. The two domains differ significantly
Róbert_Wessman
Pakistani academic
Center for Biosimilars®". "Biosimilars and Interchangeable Biologics: Tactical Elements". "Fundamentals of Modern Bioprocessing". "Biosimilarity: The FDA
Sarfaraz_K._Niazi
American oncologist and author
of Biosimilars.” JNCCN. 2017. PubMed: https://pubmed.ncbi.nlm.nih.gov/29223980/. [17] Notable because: applies behavioral economics to biosimilar uptake
Chadi_Nabhan
Association of Southeast Asian Nations
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
ASEAN
Intergovernmental organization
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
BRICS
Combination drug
medication. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Telmisartan/amlodipine
Anticoagulant medication (blood thinner)
Enoxaparin sodium Clinical data Trade names Lovenox, Clexane, Xaparin, others Biosimilars Arovi, Axberi, Axberi HP, Exarane, Exarane Forte, Enoxapo, Inclunox,
Enoxaparin_sodium
Chemical compound
complications. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Tranexamic_acid
Extension of the three-world model
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Fourth_World
programs for prescription drugs, medical devices, generic drugs, and biosimilar biological products, and for other purposes. Pub. L. 115–52 (text) (PDF)
List of acts of the 115th United States Congress
List_of_acts_of_the_115th_United_States_Congress
Medicine that stimulates red blood cell production
Commercially available agents include epoetin alfa and darbepoetin alfa, and biosimilars. Use among athletes is prohibited by the World Anti-Doping Agency. ESAs
Erythropoiesis-stimulating agent
Erythropoiesis-stimulating_agent
Country's economy that was traditionally small, but is currently expanding rapidly
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Emerging_market
COX-2 selective NSAID medication
pressure. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Etoricoxib
American pharmaceutical company
antibody medicines. In January 2023, Humira began facing competition from biosimilars. In February 2024, AbbVie acquired ImmunoGen for $10.1 billion, aiming
AbbVie
Medication legally requiring a medical prescription before it can be dispensed
prescription drugs vary widely around the world. Prescription costs for biosimilar and generic drugs are usually less than brand names, but the cost is different
Prescription_drug
SSRI antidepressant
2015. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration. 21 June 2022. Retrieved
Escitalopram
Chemical compound
2017. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Mupirocin
Nonsteroidal anti-inflammatory drug (NSAID; analgesic)
2024. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Ketorolac
Monoclonal antibody medication
this medicinal product is Celltrion Healthcare Hungary Kft. Omlyclo is a biosimilar medicinal product. It is highly similar to the reference product Xolair
Omalizumab
American biotechnology corporation
Unfortunately, many of the largest companies that would seek to enter the biosimilar market have made their money by outsourcing their research to foreign
Genentech
Developing country without coastline
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Landlocked developing countries
Landlocked_developing_countries
Chemical compound
2020. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Bimatoprost
Indian pharmaceutical company
manufacturing and marketing of pharmaceutical formulations, vaccines, biosimilars, and natural products. Panacea Drugs was set up in the year 1984 and
Panacea_Biotec
Pharmaceutical drug
November 2025, the biosimilar pertuzumab-dpzb (Poherdy) was approved for medical use in the United States as an interchangeable biosimilar to Perjeta. It
Pertuzumab
Socioeconomic classification
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Newly_industrialized_country
Dichroism with circularly polarized light
in submissions for new biologics drug applications. Particularly in biosimilars development, HOS comparisons are indispensable to meet requirements by
Circular_dichroism
Global pharmaceutical company
Actavis PLC is also developing biosimilars products in oncology and other therapeutic categories, and currently has five biosimilar products in development.
Actavis
Nations Industrial Development Organization Public health Generic drugs biosimilar Pharmaceutical patents criticism Test data exclusivity Doha Declaration
Debt Service Suspension Initiative
Debt_Service_Suspension_Initiative
Chemical compound
depression. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Zonisamide
Chemical compound
2024. "Prescription medicines: registration of new generic medicines and biosimilar medicines, 2017". Therapeutic Goods Administration (TGA). 21 June 2022
Sodium_nitrite
Mammalian protein found in humans
uncontrollable bleeding, although there have been safety concerns. A biosimilar form of recombinant activated factor VII (AryoSeven) is also available
Factor_VII
US law
generic versions of biopharmaceutical drugs (known as "biosimilars") because proving biosimilarity and quality control for biopharmaceuticals is much more
Drug Price Competition and Patent Term Restoration Act
Drug_Price_Competition_and_Patent_Term_Restoration_Act
Peptide hormone that stimulates growth
PMC 3183530. PMID 22029019. "FDA Response to three Citizen Petitions against biosimilars" (PDF), FDA, 30 May 2006, archived from the original (PDF) on June 19
Growth_hormone
Mammalian protein found in humans
reducing the necessity of daily injections. The FDA approved the first biosimilar of Neulasta in June 2018. It is made by Mylan and sold as Fulphila. Another
Granulocyte colony-stimulating factor
Granulocyte_colony-stimulating_factor
BIOSIMILAR
BIOSIMILAR
BIOSIMILAR
BIOSIMILAR
Girl/Female
Arabic
Giver; Donor
Girl/Female
Hebrew
God has judged, or God is judge. The Old Testament Daniel was a 6th century BC prophet who...
Girl/Female
American, Australian, British, Chinese, English, Jamaican, Latin
Wise; Aromatic Herb; From the Spice; Prophet; Healthy; Profound Wisdom
Boy/Male
Anglo Saxon Welsh American Celtic English Shakespearean
White.
Boy/Male
Hindu, Indian
Energetic; Warm
Girl/Female
Hindu, Indian, Sanskrit
A Bird; Nightingale; Cuckoo
Boy/Male
Tamil
Splendorous
Boy/Male
Biblical
Sorrowful, hated.
Male
Portuguese
Galician-Portuguese form of Latin Albertus, ALBERTE means "bright nobility."
Boy/Male
Hindu, Indian
Prince
BIOSIMILAR
BIOSIMILAR
BIOSIMILAR
BIOSIMILAR
BIOSIMILAR