Frequently Asked Questions (FAQ)

A generic drug is an alternative version of a branded drug which contains the same active ingredients, at the same strength, in a formulation that is considered bioequivalent to the original drug. This equivalence is verified by regulatory authorities approving the product at the country level, such as Health Canada, the U.S Foods and Drugs Agency (FDA), or the European Medicines Agency (EMA).

A biosimilar drug is a biologic agent very similar to a branded drug, although not completely identical. Like a generic drug, a biosimilar is intended as an alternative to a branded drug. The safety and efficacy of a biosimilar drug is also approved by regulatory authorities based on clinical trials before it is marketed.

The advantage offered by generic and biosimilar drugs is affordability. The active ingredients of these drugs are no longer patented and can be manufactured and sold by other companies. The price of these drugs is lower than that of branded drugs, making them an attractive option for consumers and payers.

Approved by Health Canada or other country regulators, all generic and biosimilar drugs meet the same rigorous quality standards as the original branded drug.

Yes. Country regulatory authorities are mandated to ensure that generic or biosimilar products offer the same level of safety, efficacity, and purity as original branded medicines. They ensure that this is the case by carefully reviewing the bioequivalence or clinical trials submitted by the generic or biosimilar manufacturer. Approval of the product confirms that safety, efficacy, and purity requirements have been met to the satisfaction of the regulator.

Healthcare systems face increasing strain from factors such as an aging population and the high cost of drug therapies. To ensure the long-term sustainability of health programs, cost effective measures like the use of generic and biosimilar drugs are necessary.

Generic and biosimilar drugs offer safe and effective solutions at a fraction of the cost of the branded original. They can be available at prices as low as 10% of brand. In 2022, 73% of prescriptions filled in Canada were with a generic drug.

Generic and biosimilar drugs are essential components of modern health systems, generating savings that can be reinvested to maintain program sustainability, and allow for the continued introduction of new, costly innovative medicines.

Generic and biosimilar drugs must be approved based on their safety, efficacy, purity, and quality by regulatory authorities such as Health Canada, the FDA, or the EMA.

Regulatory submissions for generic drugs are based on evidence of bioequivalence compared to the original branded drug. Complex generics may also require clinical trials. Standards of purity and quality are equivalent or superior to those of the original drug.

Biosimilar drug approval requires evidence from clinical trials that demonstrate the comparable safety, efficacy, purity, and quality of the biosimilar agent to the original biologic drug.

Bioequivalence tests are clinical trials aimed at demonstrating that two formulations of a same drug, at the same dosage, are equally safe and effective and can be interchanged. They rest on a direct comparison of the rate at which the original drug and the generic version are absorbed, distributed, and eliminated from the body. If the two formulations are within a narrow range of each other, as defined by regulatory authorities, the two products are deemed to be equivalent.

Bioequivalence is the standard international method for approving generic drugs. It has been relied upon for over 50 years around the world.

According to Research Info Source Inc., a specialized Canadian publication, Pharmascience ranks, year-in, year-out, on the list of Canada’s Top 100 Corporate R&D Spenders since 2015. With R&D spending between 40-50M$CAD a year, we as a private, Canadian-owned company have made it a strategic priority to invest in R&D. We are proud of our investments in the areas of the formulation of new generics, bioequivalence testing, and clinical research.
All Pharmascience R&D is conducted domestically and contributes significantly to pharmaceutical innovation, both in Canada and abroad.