A biosimilar is a biologic medical product highly similar to another already approved biological medicine. Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines
Biosimilars drugs—sometimes referred to as biogenerics—are highly similar versions of biologic medicines made from living microorganisms found in plant or animal cells. Biosimilar pharmaceuticals are drugs that have the same active properties as other licensed drugs.
A biosimilar is a biologic medical product (also known as biologic) highly similar to another already approved biological medicine (the ‘reference medicine’).
Biosimilars are approved according to the same standards of pharmaceutical quality, safety and efficacy that apply to all biological medicines.
Biosimilars are officially approved versions of original “innovator” products and can be manufactured when the original product’s patent expires.
Reference to the innovator product is an integral component of the approval.
Biosimilars are brand name products that are highly similar to an already existing brand name, original biologic (innovator or originator biologic) but, unlike a generic drug, are not identical.
Biologics: By comparison, biologics are very large and have complex molecular structures.
Below are 5 examples of current Biologic Drugs available:
OUR RESEARCH
Unlike with generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes.
Despite that heterogeneity, all biopharmaceuticals, including biosimilars, must maintain consistent quality and clinical performance throughout their lifecycle.
A biosimilar is not regarded as a generic of a biological medicine. This is mostly because the natural variability and more complex manufacturing of biological medicines do not allow an exact replication of the molecular micro-heterogeneity.
Drug-related authorities such as the EU’s European Medicines Agency (EMA), the US’s Food and Drug Administration (FDA), and the Health Products and Food Branch of Health Canada hold their own guidance on requirements for demonstration of the similar nature of two biological products in terms of safety and efficacy.
According to them, analytical studies demonstrate that the biological product is highly similar to the reference product, despite minor differences in clinically inactive components, animal studies (including the assessment of toxicity), and a clinical study or studies (including the assessment of immunogenicity and pharmacokinetics or pharmacodynamics).
They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which licensure is sought for the biological product.
Another key difference is that generics are copies of synthetic drugs, while biosimilars are modeled after drugs that use living organisms as important ingredients. But many experts hope the two will share a critical commonality and that, like generics, biosimilars will dramatically lower the cost of biologic drugs.
Biologic drugs are large, complex proteins made from living cells through highly complex manufacturing processes. Unlike generic drugs, which are copies of chemical drugs, a biosimilar is a copy of a biologic medicine that is similar, but not identical, to the original medicine.
The main benefit of using biosimilars in patients with inflammatory bowel disease (IBD) is reduced drug acquisition costs. Biosimilars are not generic drugs—they are highly similar to originator biologic agents—but, like generics, biosimilars are less expensive than the originators.