What is biosimilars
This article explains innovator biologics and biosimilars, biologics are very specific highly effective medicines that improve health outcomes in many complex conditions, such as Crohn's disease ulcerative colitis diabetes rheumatoid arthritis cancer osteoporosis psoriasis HIV multiple sclerosis growth deficiencies and more.
Biosimilars are products that are similar to an innovator biologic, but not identical we'll come back to that but first let's cover some background information, we are all familiar with medicines in pill form known as small molecule, they fill pharmacy shelves, they have simple molecular structures and each medicines formula is relatively simple to produce, and copy once the patent expires other companies can make a copy and sell it as a generic version, which will have the exact same active chemically derived ingredient as the innovator. these brands and their generic copies are considered by equivalent, because the generic medications are following, the simple chemical recipe of the innovator drug providing by equivalent levels of the drug in the body.
Pharmacists often substitute a small molecule with its generic, as long as there is no specific medical reason, to use the brand version. an example of small molecule medicine is the CETA salicylic acid or a SI, known by its brand name aspirin, but widely available as a generic by comparison.
Biologics are very large intricate molecules produced in living cells from highly specialized ingredients, using a complex biotechnology process which is integral to creating the final product, it is impossible to produce an exact copy, an innovator biologic is an original brand product, manufacturers must prove the medicines quality safety, and efficacy and thoroughly document, its components and processes they also conduct numerous clinical trials, treating patients who have the specific diseases, for which they seek treatment approval known as an indication.
We have been using biologic medicines for more than 200 years. initially in the form of rudimentary vaccines for smallpox as far back as 1796, another significant and widely used by logic medicine came from Canada in 1921, when doctors Banting and best extracted the hormone insulin from pigs for use in humans, to treat diabetes a previously fatal disease biologics have diversified into very sophisticated medicines, that continue to significantly improve health outcomes for patients in many disease areas.
Examples of biologics include hormones blood products, cytokines growth factors vaccines gene, cellular therapies fusion proteins, and monoclonal antibodies. patients receive biologics by injection or infusion and cannot take them orally, since the body will inactivate them during digestion, because biologics are proteins. the body can develop antibodies to them over time, which can affect how well they work, this immune response or immunogenicity might increase when switching from one biologic to another, or back again. and is a strong reason for a discussion with your healthcare professional before switching among biologic products.
Now let's talk about biosimilars as with small molecules, once the patent expires, it is legal for other manufacturers to create a biosimilar, however in the case of biologics, the innovator company is not obliged to share its patented manufacturing processes, and since there is inherent variability in a live biological system, an identical copy is not possible for an innovator biologic or biosimilar, no biosimilar will be deemed identical to its reference originator biologic, with the biologic recipes complexity biosimilar drugs are not generic.
Health Canada only approves biosimilars for marketing in Canada, when the manufacturer demonstrates that their product is of similar quality safety and efficacy to the original reference drug, however as with innovator products minor differences in production can lead to differences in clinical activity, and side-effects which might not become apparent until the product is in widespread use, there could be many different biosimilars all referencing one innovator medicine, and each would have different biological material, and manufacturing processes similar to the innovator biologic, but not to each other. Health Canada regulates biosimilars as new drugs by comparison with an innovator reference product previously authorized and marketed in Canada, decisions regarding interchangeability and substitutability of products rests with the various provincial and territorial drug regulatory bodies, as the federal authority Health Canada states that biosimilars are not generic biologics.
The cost of pharmaceuticals particularly biologics is an important consideration as experts, look at ways to make pharmaceutical care sustainable, because they are complex and have revolutionized. the treatment for many diseases biologic medicines are costly, and consume a large portion of public and private drug spending in most cases.
Biosimilars are less costly than the original biologic, due to extrapolating scientific evidence performed by the innovator, which leads to lower development costs for the biosimilar. treatment options are very important for patients who have serious health conditions with appropriate regulations in place around servile advertising, and post-market monitoring as well as private and public insurance coverage. products that demonstrate a safe and effective track record, offer new treatment options for patients biosimilars, provide additional lower-cost options for patients who are newly prescribed biologics prescribing medicines. to treat chronic conditions should remain a decision between patients and their physicians, and should not occur for purely financial reasons.