Identifying the correct medication therapy for a chronic illness can be a lengthy trial-and-error process. When an effective treatment is identified, it’s important that patients understand what kind of medication they are taking.
Of these, there are two types: small molecules, most often taken through pill, tablet, liquid or nasal sprays, and biologics, most often administered through injection or IV.
Small molecule medicines are chemically manufactured.
When the patent for a brand-name small molecule medicine expires, other companies can produce an identical copy of the active ingredient, known as a “generic.”
Biologic medicines are different—they are large molecules made from living cells …
… manufactured through complex proprietary processes that cannot be copied exactly.
When an innovator biologic patent expires, other companies can make similar copies called “biosimilars”. Biosimilars are “similar” but not identical to the innovator biologic.
Small differences between the two medicines will be unavoidable though, and regulators have determined that biosimilars are not “generic biologics.” And should not be substituted without consulting a physician. What does this difference mean for patients?
If you are a patient taking a small molecule medicine, your pharmacist may dispense a generic version without consulting your physician, or in some cases, even gaining your consent. This is an established practice because the generic and brand name small molecule medicines have identical active ingredients.
On the other hand, because biosimilars are not identical to the biologics they attempt to copy, it remains unclear what impact switching biologic medicines may have for individual patients. Yet, through something known as “non-medical switching,” your private insurer or government insurer can eliminate reimbursement for the innovator biologic medicine and only reimburse the biosimilar version – resulting in a switch to a biosimilar for reasons unrelated to your health. Therefore, switching could be a problem because if you are a patient requiring a biologic treatment, it often takes time to identify the medicine that stabilizes your condition. And switching to a medicine that does not have identical active ingredients may have consequences.
Biosimilars have the potential to offer broader access to lifesaving medicines. They increase market competition which may result in lower costs for payers – the government or private insurers who are covering the cost for patients. However, patient safety must remain paramount. Only physicians have the knowledge and understanding of their patients’ individual medical needs—patients should not be forced to switch from one therapy to another based on cost. Patients and physicians should remain in control of their treatment decisions, based on the best medical interest of the patient. Physician-patient relationship and decision-making process must be preserved.
For more information, visit www.safebiologics.org.