The Totality of Evidence

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By Carol Kirchhoff and Shefali Kakar

Carol Kirchhoff-finalKakar Shefali-finalBiosimilar is the term used to describe a biological therapeutic that has been developed to be highly similar to a marketed biological therapeutic (reference) product that has exhausted its patent protection and is approved via a stringent regulatory pathway. By 2020, biologics that have exhausted their patents are estimated to represent over $80 billion in sales. Development of biosimilars potentially represents not only billions of dollars in health care savings but also a significant increase in patient access. This concept has been well recognized for small molecule reference products and their corresponding generics and is beginning to translate to large molecules with recently developed approval pathways globally. Continue reading

Let the Games Begin! FDA Approves Filgrastim Biosimilar

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By Robert g. Bell

Robert BellAs many are aware, the Food and Drug Administration (FDA) approved its first biosimilar using the recently enacted abbreviated licensure pathway under section 351(k) of the Public Health Service Act. In March 2015, Novartis-Sandoz Zarxio (filgrastim-sndz) was approved as biosimilar with the same indications to Amgen Inc.’s Neupogen (filgrastim). The Zarxio approval was based on physical, chemical, biological, preclinical, pharmacokinetic, pharmacodynamic, clinical, safety, and immunogenicity comparisons that demonstrated Zarxio is biosimilar to Neupogen. It is important to note that although Zarxio was approved as biosimilar, it was not approved as an interchangeable or “switchable” product as per 351(k)(4), since the cost savings to health care result not only in use but substitution of the biosimilar for the reference biologic. Continue reading

Drug Discovery Paradigm Shift? Strategies to Improve Science, Timelines, and Clinical Candidate Quality

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By Patrice L. Jackson-Ayotunde and Annette Bak

Patrice Jackson-finalAnnette BakOver the past decade, there has been a decrease in the number and rate of new drug candidates that are being translated into effective therapies for clinical use. Approximately only five out of every 10,000 new chemical entities make it into phase I clinical trials. In addition, approximately only one out of these five is approved for the marketplace. Underlying scientific causes of attrition are mainly lack of efficacy, toxicity, and pharmacokinetics/formulation related events. Therefore, in order to select drug development candidates effectively, it is important that the discovery and preclinical disciplines collaborate on selecting a candidate with good probability of success in clinical development. This will be a drug candidate with compelling efficacy and a suitable physicochemical, formulation, ADME, and toxicology profile. Continue reading

AAPS Pharmaceutical Science Roundup, April 2015

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tenmplate for set 6This month’s roundup features stories on editing DNA in human embryos, expensive insulin, rights of chimps, tumor paint, and even a head transplant!

Have a perspective on one of these stories? Submit your post to the AAPS Blog! Continue reading

AAPS Asks Kids: If You Could Develop Any Medicine, What Would It Be?

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Yesterday was the official Take Our Daughters and Sons to Work Day, and the American Association of Pharmaceutical Scientists (AAPS) welcomed five awesome kids for an educational, interactive overview of life at AAPS. This year’s theme is #MPOWR, and we embraced it by asking our guests: “If you could develop any medicine, what would it do, and what would it look like?” Their inspiring answers are below: Continue reading

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