Biosimilars

Extracted Attributes

• Type

  Biologic medical product

• Primary Goal

  Lower drug prices through market competition

• Reference Product

  Original innovator biologic with expired patent

• Manufacturing Source

  Living organisms (animal/plant cells, bacteria, yeast)

• Molecular Complexity

  High; sensitive to manufacturing changes

• Regulatory Requirements

  Analytical studies, animal testing, and clinical trials (safety, efficacy, immunogenicity)

Timeline

• The European Medicines Agency (EMA) grants the first marketing authorizations for biosimilars in the European Union. (Source: Wikipedia)

  2006-01-01

• The World Health Organization (WHO) publishes international guidelines for the evaluation of similar biotherapeutic products. (Source: Wikipedia)

  2009-01-01

• The first biosimilar of a monoclonal antibody (infliximab) is approved for use in the European Union. (Source: Wikipedia)

  2013-01-01

• The FDA approves the first biosimilar in the United States, filgrastim-sndz (trade name Zarxio) by Sandoz. (Source: Wikipedia)

  2015-03-06

• FDA Commissioner Marty Makary outlines a strategy at the JP Morgan Healthcare Conference to accelerate biosimilar approvals to lower drug prices. (Source: Document 065d2e96-4d40-49bd-8511-d8d35f8b01f4)

  2024-01-01

Biosimilar

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 product that is manufactured by a different company. Biosimilars are officially approved versions of original "innovator" products and can be manufactured when the original product's patent expires. Reference to the innovator product is an integral component of the approval. Unlike with generic drugs of the more common small-molecule type, biosimilar drugs generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite this heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle. Drug-related authorities such as the European Medicines Agency (EMA) of the European Union, the United States Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy. According to them, analytical studies demonstrate that the biological product is highly similar to the reference product, despite minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics). They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which licensure is sought for the biological product. The World Health Organization (WHO) published its "Guidelines for the evaluation of similar biotherapeutic products (SBPs)" in 2009. The purpose of this guideline is to provide an international norm for evaluating biosimilars. The EMA has granted marketing authorizations for more than 50 biosimilars since 2006. The first biosimilar of a monoclonal antibody to be approved worldwide was a biosimilar of infliximab in the EU in 2013. On March 6, 2015, the FDA approved the United States' first biosimilar product, the biosimilar of filgrastim called filgrastim-sndz (trade name Zarxio) by Sandoz.

Web Search Results

• Biosimilars - Vanderbilt Specialty Pharmacy

  # What are Biosimilars? Biosimilars are safe and effective medications approved by the U.S. Food & Drug Administration (FDA). They are called biosimilar because they are a type of medication known as "biologics" (medications created from living organisms and designed to target a certain site in the body) and are made in a way that mirrors the process of a biologic medication that has already been approved by the FDA (often referred to as the reference product). Biosimilars work the same way in your body as the reference product. Any differences between the biosimilar and the reference product are carefully reviewed by the FDA before the biosimilar is approved to ensure the biosimilar is as safe and effective as the reference product. [...] Biosimilars are not generics of the reference product. Generic drugs are considered “simple molecules” and are an exact copy of the brand name drug. Biosimilars are complex molecules that require a specialized manufacturing process to create a similar product. Like generics, biosimilars are often less expensive than the original product. The lower cost is not a reflection of the effectiveness or safety of the biosimilar but a result of increased supply and faster development with the use of available information from the reference product. Many biosimilar manufacturers offer a copay savings program to help with any out-of-pocket expense. Biosimilars are: •As effective as the reference product •As safe as the reference product, having the same potential side effects

• Biosimilar medicines: Overview

  A biosimilar is a biological medicine highly similar to another biological medicine already approved in the EU (called 'reference medicine') in terms of structure, biological activity and efficacy, safety and immunogenicity profile (the intrinsic ability of proteins and other biological medicines to cause an immune response). The EU approved the first biosimilar in 2006. A biosimilar is not regarded as a generic of a biological medicine. This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular micro-heterogeneity. The EU has pioneered the regulation of biosimilar medicines by establishing a solid framework for their approval and by shaping biosimilar development globally. [...] # Biosimilar medicines: Overview A biosimilar is a biological medicine highly similar to another already approved biological medicine (the 'reference medicine'). Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines. The European Medicines Agency (EMA) is responsible for evaluating the majority of applications to market biosimilars in the European Union (EU). HumanBiosimilarsRegulatory and procedural guidance Biological medicines offer treatment options for patients with chronic and often disabling conditions such as diabetes, autoimmune disease and cancers.

• Biosimilar Medicines | American Cancer Society

  ## What is a biosimilar? A biosimilar, or biosimilar medicine, is a medicine that is very close in structure and function to an existing brand name biologic medicine. The original biologic medicine is known as the reference product and has already been approved for use in the United States. A biosimilar behaves in much the same way as its brand name biologic, so there are “no meaningful differences" between how the two medicines work. This means that the biosimilar is considered as safe and effective as the biologic reference product. According to the US Food and Drug Administration (FDA), when compared to their brand name biologic (reference product), a biosimilar: [...] Download Section as PDF # Biosimilar Medicines Biosimilars are more affordable alternatives to a specific class of medicines called biologics, including some immunotherapies used to treat many types of cancer. While they are not exact copies, biosimilars follow strict FDA guidelines to ensure they work the same and are just as safe as brand name biologic medicines. On this page [show] [hide] What is a biosimilar? What is a biologic? Are biosimilars the same as generic drugs? Are biologics and biosimilars interchangeable? Are biosimilars safe? Are biosimilars cheaper? Examples of biosimilars used in cancer treatment ## What is a biosimilar? [...] Poherdy\ Biosimilars for the biologic medicine filgrastim (Neupogen): Zarxio Nivestym Releuko Nypozi Biosimilars for the biologic medicine pegfilgrastim (Neulasta): Fulphila Udenyca Ziextenzo Nyvepria Fylnetra Stimufend Armlupeg Biosimilar for the biologic medicine epoetin alfa (Epogen or Procrit): Retacrit Biosimilars for the biologic medicine denosumab (Xgeva): Wyost\ Xbryk Osenvelt\ Bomyntra\ Bilprevda Aukelso Extrenbo Jubereq \This product is FDA approved as interchangeable with its brand name biologic. (See 'Are biologics and biosimilars interchangeable?', above.) Flyer: Biosimilar Medicines for Cancer Treatment Get quick facts about biosimilars and questions to ask your cancer care team in this flyer. 1. Written by 2. References

• What Are Biosimilars? - Cleveland Clinic

  Abu Dhabi|Canada|Florida|London|Nevada|Ohio| 855.733.3712|MyChart|Need Help?|Careers|Donate Now| Find a ProviderLocations and DirectionsServicesPatients and VisitorsHealth Library Find a Provider Locations and Directions Services Patients and Visitors Health Library Home/ Health Library/ Medical Treatments/ Biosimilars Advertisement Advertisement # Biosimilars Biosimilars are medications that treat a range of chronic diseases. They’re similar to medicines made from living organisms called biologics. Like biologics, they go through rigorous testing before receiving FDA approval. They’re made of the same types of organic material and offer the same benefits. But usually, they’re much less expensive. Advertisement [...] | Biologic | Biosimilars | --- | | aflibercept (Eylea®) | Eydenzelt®, Opuviz™, Yesafili™ | | adalimumab (Humira®) | Abrilada®, Amjevita®, Cyltezo®, Hadlima®, Hulio®, Hyrimoz®, Idacio®, Yuflyma®, Yusimry®, Simlandi® | | bevacizumab (Avastin®) | Alymsys®, Avzivi®, Jobevne®, Mvasi®, Vegzelma®, Zirabev® | | denosumab (Prolia®, Xgeva®) | Jubbonti®, Wyost® | | eculizumab (Soliris®) | Bkemv®, Epysqli® | | etanercept (Enbrel®) | Erelzi®, Eticovo® | | infliximab (Remicade®) | Avsola®, Inflectra®, Ixifi®, Renflexis® | | insulin glargine (Lantus®) | Rezvoglar®, Semglee® | | pegfilgrastim (Neulasta®) | Fulphila®, Fylnetra®, Nyvepria®, Stimufend®, Udenyca®, Ziextenzo® | | ranibizumab (Lucentis®) | Byooviz®, Cimerli® | | rituximab (Rituxan®) | Riabni®, Ruxience®, Truxima® | [...] Advertisement Cleveland Clinic is a non-profit academic medical center. Advertising on our site helps support our mission. We do not endorse non-Cleveland Clinic products or services.Policy Care at Cleveland Clinic Cancer Care Cancer Care for Children Make an Appointment ContentsOverviewRisks / BenefitsWhen To Call the Doctor ## Overview ### What are biosimilars? Biosimilars are medications that are similar to medicines called biologics. Biologics come from living things, like animal and plant cells, bacteria and yeast. This can make them harder and more costly to produce than synthetic drugs. Advertisement

• Biosimilars - FDA

  # Biosimilars Biosimilars are safe and effective treatment options for many illnesses such as chronic skin and bowel diseases (like psoriasis, irritable bowel syndrome, Crohn’s disease and colitis), arthritis, kidney conditions, and cancer. Biosimilars increase access to lifesaving medications at potentially lower costs. Explore the website to learn more about biosimilars and to access all FDA’s educational resources for health care providers and patients. Sub-Topic Paragraphs ## Biosimilar Pages ### Basics for Patients Find useful information on biologics, including biosimilars ### Overview for Health Care Professionals Learn about biologics, including biosimilars and interchangeables ### Review and Approval