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Regulatory Focus™ > News Articles > 2019 > 2 > Shakeup at the Top of FDA’s Biosimilars Division

Shakeup at the Top of FDA’s Biosimilars Division

Posted 01 February 2019 | By Zachary Brennan 

Shakeup at the Top of FDA’s Biosimilars Division

The US Food and Drug Administration (FDA) on Friday announced that Leah Christl, director of the Therapeutic Biologics and Biosimilars Staff (TBBS) in the Office of New Drugs (OND), has decided to leave FDA and will depart 22 February. Christl is moving to Amgen.

Amgen told Focus Christl will be joining as executive director, global regulatory and R&D policy on 11 March.

After joining FDA in 2003, Christl since 2010 has been at the forefront of biosimilar policy and regulations at FDA and was the lead expert in both of the user fee agreements for biosimilars.

A frequent speaker at industry and other conferences, Christl “was instrumental in policy development and the interpretation and implementation of the Biologics Price Competition and Innovation (BPCI) Act for CDER and FDA, which has led to 17 FDA approved biosimilars to date,” according to an email from CDER Director Janet Woodcock and OND Director Peter Stein.

Replacing Christl as acting director of TBBS is Sarah Yim, who is currently director of the Division of Clinical Review in the Office of Bioequivalence (OB), Office of Generic Drugs (OGD).

She joined FDA in 2005 as a medical officer in the then Division of Anesthesia, Analgesia, and Rheumatology Products in CDER, gaining experience in IND stage development and in conducting comprehensive NDA/BLA reviews. She was promoted to lead medical officer in 2007 and led the transition of the rheumatology group as the new Division of Pulmonary, Allergy, and Rheumatology Products (DPARP) was formed in 2010.

“Sarah brings outstanding knowledge of biological and biosimilar development, a strong scientific and clinical background, and collaborative management and leadership skills. Sarah will work closely with the TBBS staff and Leah Christl in February, and she will officially assume her TBBS position in the beginning of March,” according to an email from Stein.


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