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The availability of biological medicines such as Epoietin has saved many lives, and improved the quality of life for patients. These medicines are expensive, and are not coming down in price, because of the absence of competition. For many years, originators and regulatory authorities argued that these medicines could not be “copied”. However, the increasing drug budgets, aging populations and reducing tax revenues has made the creation of a regulatory pathway for the development of biosimilars an economic imperative. However, there are regulatory constraints within which companies must operate.
The regulatory oversight and development of biosimilar medicines requires a unique blend of experiences, including NCE/NBE development, generic development experience, global regulatory affairs experience.
Speid & Associates, Inc.
Speid & Associates provide services in the global regulatory affairs and development of biosimilars. These services cover all types of biosimilars, from the relatively small in size tthe very complex. These services cover ICH countries, but include services tassist companies based in non-ICH countries tsecure registration of biosimilars in ICH countries.
Dr. Lorna Speid’s Experience
Download the Biosimilars Brochure
Dr. Speid is a recognized expert in the development of biosimilars. The White Paper on Biosimilars was published on BIOSIMILAR NEWS, and demonstrates her understanding and grasp of the US regulatory system for biosimilars. See White Paper
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Contact Dr. Speid at 858 793 1295 or at firstname.lastname@example.org
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