Biosimilar debate heats up at BIO
18 June 2008
Speakers at the 2008 BIO International Convention in San Diego yesterday discussed the regulatory and scientific issues created by generic biological drugs, commonly known as biosimilars or follow-on biologics
Biosimilars are products that attempt to replicate biologics – medicines which involve living organisms – and are similar, but not identical to, the innovator drug. Like their pharmaceutical counterparts, they are offered at discounted prices to patients.
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.
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