I have obtained an invitation to participate in a webinar "Biosimilars: Nonclinical and Clinical Development Challenges and Considerations"
Biosimilars are biologicals and are very attractive approach for Big Pharma in terms of
1. High complexity
2. Low efficiency
3. High price
And organizers of the webinar are aware of the situation:
With many blockbuster biological drugs now, or soon to be off patent, there has been great interest in developing follow-on versions, termed biosimilars. Biosimilars have emerged as one of the fastest growing development opportunities in the biopharmaceutical sector. Unlike generic small molecule drugs creating an exact copy of a therapeutic protein is impossible. As a result regulatory agencies evaluate this category of biologics based on their level of similarity to, rather than the exact replication of the innovator drug.
Do you need any further clarifications? No, just "copy-paste" or "me-too" business!
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