As more BioSimilar medicine is available in the US market, your healthcare provider may decide that treatment with a BioSimilar medicine is right for you. Please take a look at some common questions and answers below, and do not hesitate to contact your Senderra Pharmacist with any additional questions.
A BioSimilar (also known as BioSim) is a biologic medicine, produced from living organisms, and is designed to work just like FDA-approved biologic medicine, known as the reference medicine. BioSimilar treatment options are available for chronic diseases including rheumatoid arthritis, inflammatory bowel disease, psoriasis, and certain cancers, like urologic cancer and dermatologic cancer.
The FDA undertakes a comprehensive approval process to determine whether a BioSimilar is approved for medical use in the United States. This is because, like all biologics, BioSimilars are developed in living cells and require a high level of scientific expertise to create.
BioSimilars undergo a rigorous review process to ensure they have the same safety and effectiveness as their reference medicines. To be approved, a BioSimilar must show it has no clinically meaningful differences to the reference biologic in terms of quality, safety, and its ability to produce the desired outcome in patients.
BioSimilar medicines are manufactured with the same high degree of quality as any other biologics manufactured at the pharmaceutical company. All BioSimilars must meet the robust regulatory standards of the FDA before they can be approved for use. The FDA uses research, clinical studies, and data to make sure a BioSimilar works as well as its reference medicine. Once approved, all BioSimilars undergo comprehensive monitoring to ensure patient safety and effectiveness.
>> See here for more FDA related questions.
Yes and a BioSimilar will also follow the same treatment schedule as the original biologic.
If your biologic treatment is given through an intravenous (IV) infusion at a doctor’s office, hospital, or infusion center, you will receive your BioSimilar the same way.
If you self-inject your biologic treatment at home, you will still give yourself an injection, but you may be switched to a different type of injector device. Your Pharmacist will discuss this change with you. Please consult with your physician for the best treatment course for you.
Senderra offers specialized immunology treatments for more than 15 specialties including autoimmune disorders, like rheumatoid arthritis, MS, psoriasis, alopecia, chronic asthma, lupus, gastroenterology, immune system disorders, dermatologic diseases, and more.
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Senderra is a national specialty pharmacy, serving patients with challenging and ongoing medical conditions, like autoimmune disorders, through provision of specialty medications, clinical expertise and support services.
We dedicate ourselves to designing and executing a model to serve the needs of our patients and partners (Prescribers, Pharma and Payers) in order to make a difference and effect positive outcomes.
Disclaimer:
No content on this site, regardless of date, should ever be used as a substitute for direct medical advice from your doctor or other qualified clinician.
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