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Thus, the key to biosimilar development is the demonstration of a high degree of molecular similarity, as well as adequate safety and efficacy data to achieve commercial viability (represented by a broad product label).

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Certican for use in other non-oncology indications and is exclusively licensed to Abbott and sublicensed to Boston Scientific for use in drug-eluting stents.

If a nonclinical immunogenicity evaluation were performed, the primary purpose would be to enable a valid interpretation of the nonclinical findings, rather than to predict immunogenic potential in humans.

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It must not be used in patients who have developed pure red cell aplasia (reduced or stopped red blood cell production) following treatment with any erythropoietin, patients with hypertension (high blood pressure) that is not controlled, patients about to undergo surgery who have severe cardiovascular (heart and blood vessel) problems including a recent heart attack or stroke, or patients who cannot receive medicines to prevent blood clots.

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