WHY should patients be involved in the biosimilars debate?
Medicinal products developed through biotechnology constitute an essential part of medicines available to patients today. Biosimilars are products that attempt to replicate biologics – medicines which involve living organisms – and are similar, but not identical to, the innovator drug. But because biosimilars are based on biologics, which are more complex than the small molecule chemical drugs copied by generic pharmaceutical companies, it is not yet possible to make them identical to the reference product, and this has made it necessary for regulators to develop alternative approval processes than those used for traditional generic drugs. Patients need to contribute their views actively to biosimilars debate to ensure that cost effective biotechnology-derived therapies are made available to them as quickly as possible. Patients should discuss access, cost, safety and efficacy of receiving biosimilar medicines as these are now an emerging source of affordable medicines for more patients with some of the most difficult to treat diseases.
For more detailhttp://www.egagenerics.com/FAQ-biosimilars.htmhttp://www.managingip.com/Article/1958965/Biosimilar-debate-heats-up-at-BIO.html
What is this "small difference" that makes biosimilar product not identical to original?
This small but sometimes decisive difference between the old and the new class of drugs are seen as an opportunity to some and a danger to others, depending on which side of the fence they stand. Thus, doctors, pharmacists and patients should know whether they can be sure if the less expensive biosimilar medicine, once it is approved for sale, is bioequivalent to the original drug (treatment) or whether it can be used instead of the original to treat specific diseases.