Biosimilars Provide New Treatment Opportunities For Wide Range of Conditions

Biosimilars are, by definition, very similar to medications that have been approved by FDA. Often, the original drug approved is called the reference product. These similar drugs have the same clinical efficacy and safety as their reference drugs already approved. Some biosimilars are made from sugars, proteins, living cells, animal and plant cells, micro-organisms such as bacteria or yeast, or combinations of these components. They are usually made with a more complex structure compared to their reference drugs and are therefore more complicated to purify, process, and make.¹

Crucially, biosimilars are made from the same types of sources as their reference products, provide the same benefits in disease treatment and management, and are usually prescribed and administered at the same strength and dosage as the reference product. Many of these products also have the same or similar adverse effects as their reference drugs. ¹

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Some key biosimilars are indicated for chronic skin diseases such as psoriasis; for bowel diseases such as Crohn disease and irritable bowel syndrome; for diabetes; macular degeneration; arthritis; kidney disease; multiple sclerosis; and cancers such as breast, colon, and lung cancers.¹

Like all drugs, biosimilars undergo a lengthy evaluation process by the FDA to prove their efficacy and quality. Many times, biosimilars are approved through an abbreviated drug application process pathway that may avoid the need for lengthy clinical trials due to their known similarity with the reference product. Biosimilars are proven to be highly similar to the original products with no clinical meaningful differences.²

Biosimilars and generic drugs are both compared and tested against the brand name drugs in clinical studies. The brand name drugs are approved through many clinical studies for their FDA approvals, while both biosimilars and generic drugs go through shortened FDA review process. Importantly, both generics and biosimilars are less expensive than their brand name counterparts.

However, biosimilars and generics are different in that biosimilar drugs are made from a biologic source, while the generic drug is made from chemicals. Biosimilar drugs are the same as their brand name counterparts, while the generics are the exact chemical copy of the related brand name. Additionally, approved biosimilar drugs need to go through a special approval process to be considered interchangeable with the brand name biologic, whereas the generic drug can be automatically substituted for the brand name drug.³

Some interchangeable biosimilars include Semglee (insulin glargine-yfgn; Lantus), approved in July 2021, and Rezvoglar Kwikpen (insulin glargine-aglr; Lilly), approved in Dec 2021. Others include Cyltezo (adalimumab-adbm; Boehringer Ingelheim), an interchangeable to Humira approved in October 2021; Cimerli (ranibizumab-eqrn; Coherus Biosciences), approved as an interchangeable to Lucentis in August 2022; Byooviz (ranibizumab-nuna; Biogen), approved in October 2023; and Wezlana (ustekinumab-auub; Amgen), approved in Oct 2023.⁴

Some biosimilar drugs are used in oncology. Biosimilars for bevacizumab (Avastin; Genentech) include Mvasi, Zirabev, Alymsys, Vegzelma, and Avzivi. For biologic drug trastuzumab (Herceptin; Genentech), biosimilars include Ogivri, Herzuma, Ontruzant, Trazimera, and Kanjinti. Biosimilars for rituximab (Rituxan; Genentech and Biogen) include Truxima, Ruxience, and Riabni. Biosimilars for filgrastim (Neupogen; Amgen) include Zarxio, Nivestym, and Releuko. Lastly, biosimilars for pegfilgrastim (Neulasta; Amgen) include Fulphila, Udenyca, Ziextenzo, Nyvepria, Fylnetra, and Stimufend.⁵

The FDA’s Purple Book database can be used as a resource for health care professionals to look into interchangeable options between a reference biologic and a biosimilar drug. The Purple Book can be accessed through the FDA website. This source has been developed by the FDA to list each of the reference biological products, the biosimilar, and interchangeable biological products.⁴

For many patients impacted by diseases such as cancer or rheumatology diseases, biosimilar drugs present new options not only from a clinical standpoint, but also from a cost and affordability standpoint. The future of medicine could be impacted by many of these biosimilar options.

References

1. Biosimilar Basics for Patients. FDA. Reviewed October 26, 2023. Accessed January 15, 2024. https://www.fda.gov/drugs/biosimilars/biosimilar-basics-patients#:~:text=A%20biosimilar%20is%20a%20biologic,differences%20from%20the%20reference%20product.

2. Overview for Health Care Professionals. FDA. Reviewed December 13, 2022. Accessed January 15, 2024. https://www.fda.gov/drugs/biosimilars/overview-health-care-professionals

3. What Are Biosimilar Drugs? American Cancer Society. Revised April 27, 2022. Accessed January 15, 2024. https://www.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs/what-are-biosimilars.html

4. What are biosimilar drugs? Drugs.com. Updated November 1, 2023. Accessed January 15, 2024. https://www.drugs.com/medical-answers/what-biosimilar-drugs-3573970/

5. List of Biosimilar Drugs Used in Cancer Treatment. American Cancer Society. Revised December 8, 2023. Accessed January 15, 2024. https://www.cancer.org/cancer/managing-cancer/treatment-types/biosimilar-drugs/list.html