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FDA Releases Biosimilar Guidance, Medicare Will Cover Infliximab-dyyb & More

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References

  1. Ruoff A. FDA completes guidance on developing biosimilars. Bloomberg. 2016 Dec 29.
  2. U.S. Food and Drug Administration. Clinical pharmacology data to support a demonstration of biosimilarity to a reference product: Guidance for industry. 2016 Dec 28.
  3. U.S. Food and Drug Administration. FDA approves Inflectra, a biosimilar to Remicade. 2016 April 5.
  4. Walsh N. Medicare to cover infliximab biosimilar: Cost to system is 15% lower than original Remicade. MedpageToday. 2017 Jan 6.
  5. Janssen Pharmaceutical Co. News release: Janssen submits two applications to FDA seeking approval of Simponi Aria (golimumab) for the treatment of active psoriatic arthritis and active ankylosing spondylitis. 2017 Dec 20.
  6. Deodhar AA, Reveille JD, Harrison DD, et al. Safety and efficacy of intravenous golimumab in adult patients with active ankylosing spondylitis: Results through Week 28 [abstract]. Arthritis Rheumatol. 2016;68(suppl 10).

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