OUR POSITION STATEMENT ON BIOSIMILARS:
THE DECISION TO USE A BIOSIMILAR (OR A BIOLOGIC) MUST SOLELY BE IN THE HANDS OF THE PATIENTS LIVING WITH PSORIATIC DISEASE AND THEIR PHYSICIAN.
WHAT IS A BIOSIMILAR?
Biosimilars (previously referred to as a subsequent entry biologic or SEB) are medications that are similar to, but not identical versions of an existing biologic (also called an innovator or reference drug). Biosimilars are often mistakenly called "generic” versions of the innovator drug, however generics are exact copies of the innovator drug with the same medicinal ingredients. Biosimilars are only similar to their reference drug since biologics are large molecules that are produced by living organisms and therefore it is not possible to make an exact copy of them.
WHAT IS A BIOLOGIC?
A biologic is a protein-based drug that is produced from living cells. They are often used in the treatment of severe psoriasis and psoriatic arthritis and are administered by injection or intravenous (IV) infusion. Biologics target and block the cells responsible for inflammation in the body (such as TNF-Alpha (tumor necrosis factor-alpha), interleukin 17-A or interleukins 12 and 23.) These cells and proteins all play a major role in developing psoriasis and psoriatic arthritis.
WHAT IS HEALTH CANADA’S DEFINITION OF A BIOSIMILAR?
“A biologic drug that obtains market authorization subsequent to a version previously authorized in Canada, and with demonstrated similarity to a reference biologic drug. A biosimilar relies in part on prior information regarding safety, efficacy and effectiveness that is deemed relevant due to the demonstration of similarity to the reference biologic drug and which influences the amount and type of original data required.” (Source: http://www.hc-sc.gc.ca/dhp-mps/brgtherap/applic-demande/guides/biosimilars-biosimilaires-eng.php#def.)
1. CAPP recognizes the potential benefits to patients with the entry of biosimilars, including decreased health care costs and increased access. Patients should not however, be forced to switch from one treatment therapy to another.
2. A biosimilar must not be considered for automatic substitution or be interchangeable with their reference biologic by physicians, pharmacists, public or private insurers.
3. Biosimilars now have a distinct non-proprietary name in order to avoid confusion and ensure that no accidental substitution occurs or incorrect perception that they are identical to their reference biologic. This also facilitates accurate attribution of adverse effects.
4. Since Health Canada approves a biosimilar based on the safety and efficacy data of the reference drug (or based on the results of testing for a different disease indication), there must be a critical requirement for vigilant post market safety reporting and monitoring for any adverse events.
5. Producers of biosimilars are encouraged to provide a robust platform of patient and physician support programs to accompany the treatment. Similarly, payers are encouraged to look at the full cost to the health care system, not simply the cost of the medication.