Biosimilars

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

• Dr. Speid has been working on global regulatory strategies for biosimilars/biobetters since 1999.
• Global regulatory affairs
• Registered novel drugs in all major health authorities
• Expert in the development of global regulatory strategies
• Expert in the development of meeting strategies for meetings with Major Health Authorities
• New Biological Entity experience
• Development of regulatory strategies for biosimilars
• Biobetter experience – pegylation technologies
• Monoclonal antibodies
• Polyclonal antibodies

Download the Biosimilars Brochure

Services

• Global strategic regulatory affairs
• US regulatory affairs
• European regulatory affairs
• Regulatory affairs for ICH countries
• Program management approach tinclude overseeing all aspects of the development of biosimilars
• IND preparation and submission, including Pre-IND meeting strategies.
• BLA and MAA preparation and submission

See Brochure

White Papers

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

CALL DR. SPEID NOW!

Contact Dr. Speid at 858 793 1295 or at lspeid@sndtm.com