Biosimilars of Orphan Drugs

The term “biosimilar” describes officially approved subsequent versions of innovator biopharmaceutical products made by a different sponsor, following patent and exclusivity expiry on the innovator product.

Biosimilars are similar to original biological product which have already been authorized,and do not differ much from the original product in terms of quality, safety and efficacy. As such, biosimilars are “copies” of biological medicines which have already been approved, and they generally come on the market at a significantly reduced price compared to the original, granting access to more patients.

For Orphan Drugs, despite the specific « enlarged » patent protection given by Orphan Drug status, biosimilars constitute the beginning of a brand new era, by fostering access to all patients in need, especially in emerging countries.

Today, payers are alert to the cost savings potential of biosimilars, and there can be little doubt that the pressure to drive down prices will continue unabated. Those payers, especially public ones, will have the capability to change the game very quickly.

CarthaGenetics® has recently developed this new pole of expertise dedicated to the introduction of orphan drugs biosimilars in emerging countries like Algeria, Tunisia and Morocco, representing an area of over 82M inhabitants.

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