Part 2: Nancy Globus on Whether or Not Biosimilar Naming Causes Confusion
August 13th 2020Nancy J. Globus, PharmD, vice president of Regulatory Affairs at the Accreditation Council for Medical Affairs (ACMA), discusses the truth behind 4-letter suffixes and product confusion among physicians and pharmacists.
Part 2: Axinn Patent Attorneys Discuss New Challenges for Insulins Under the BPCIA
July 23rd 2020Ted Mathias and Stacie Ropka, PhD, intellectual property law partners with Axinn, Veltrop and Harkrider LLP, discuss patent disputes and interchangeability designations with regard to insulin products under the Biologics Price Competition and Innovation Act (BPCIA). This is Part 2 of the interview. To watch Part 1, click here.
Rathore Discusses Study on Biosimilar Application Failures
July 22nd 2020The Center for Biosimilars® interviewed Anurag S. Rathore, PhD, whose team of investigators evaluated why applications for biosimilar approvals do not succeed. Large companies as well as small find the approval process challenging, but there is a learning curve that may be followed by more consistent approvals, he explains.
Part 1: Axinn Patent Attorneys Discuss Insulins Under the BPCIA vs Hatch-Waxman
July 21st 2020Ted Mathias and Stacie Ropka, PhD, intellectual property law partners with Axinn Veltrop and Harkrider LLP, met with The Center for Biosimilars® to discuss how insulins will be regulated under the Biologics Price Competition and Innovation Act (BPCIA) versus the Hatch-Waxman Act, as well as the new challenges follow-on manufacturers will face.
Celltrion: Infliximab Biosimilar Shows Promise for COVID-19
July 14th 2020Byoungseo Choi, head of marketing for Celltrion Healthcare, discusses how Celltrion's infliximab biosimilar can aid in the treatment of coronavirus disease 2019 (COVID-19)–related inflammation, as well as the company’s launch plans for biosimilars through 2030.
Kathy Oubre: Other Players Complicate Biosimilar Use for Cancer Centers
July 2nd 2020Kathy Oubre, chief operating officer at the Pontchartrain Cancer Center in Louisiana, president of the Louisiana Medical Group Management Association and member of the board of directors for the Community Oncology Alliance, discusses how payers, pharmacy benefit managers, and manufacturers make providing biosimilars complicated for patients and providers.
Ryan Haumschild, PharmD, Outlines Ways to Boost Physician Confidence in Biosimilars
July 1st 2020Ryan Haumschild, PharmD, director of pharmacy at Emory Healthcare in Atlanta, Georgia, discussed results to the survey he conducted on biosimilar utilization and planned initiatives about how to increase physician confidence in biosimilars.
Part 2: Nick Mitrokostas on the Race for the First Interchangeable Biosimilar
June 24th 2020Nick Mitrokostas, an intellectual property law attorney with Goodwin Proctor in Boston and editor-in-chief of Big Molecule Watch, discussed the building anticipation for the first interchangeable biosimilar and whether the FDA is doing enough to facilitate the development of more biosimilars and quell anticompetitive practices.
Part 1: Nick Mitrokostas on How COVID-19, FDA Rule Changes Are Shaping the Biosimilar Market
June 23rd 2020Nick Mitrokostas, an intellectual property law attorney with Goodwin Proctor in Boston and editor in chief of Big Molecule Watch, discussed the impact on the US biosimilar market from the coronavirus disease 2019 (COVID-19) pandemic and the recent change to the Biologics Price Competition and Innovation Act (BPCIA).
Part 2: Christine Simmon Discusses Payer Influence on Provider Behavior
June 18th 2020Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discussed the new pathway for insulin biosimilars and the struggles between payers and providers over biosimilar choice.
Part 1: Christine Simmon Discusses the Individual Mandate and Biosimilars
June 16th 2020Christine Simmon, executive director of the Biosimilars Council and senior vice president of policy and strategic alliances at the Association for Accessible Medicines (AAM) discusses potential legislation that the AAM is advocating for and how the upcoming election and Supreme Court decision will affect biosimilars.
Joseph Fuhr, PhD, Discusses Competition for the Growing Biosimilar Market
June 10th 2020Joseph P. Fuhr Jr, PhD, professor emeritus of economics at Widener University in Chester, Pennsylvania, and an expert on antitrust health economics and pharmacoeconomics discusses how future biosimilar competition will affect consumers and market development.
Ha Kung Wong and April Breyer Menon Discuss Promising and Not-so-Promising Biosimilar Legislation
June 5th 2020An extended interview with Ha Kung Wong, JD, an intellectual property law attorney and partner at Venable Fitzpatrick in New York and April Breyer Menon, JD, an expert on biosimilar patent law and founder of April Breyer Consulting in Chicago discussing potential biosimilars legislation.