Interviews

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains how the upcoming transition of follow-on biologics to regulation as biosimilars could create a "regulatory dead zone."

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses the impact of prior authorization requirements on patients and providers.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, explains how "fail-first" policies, or step therapy, affect patients.

Seth Ginsberg, co-founder and president of the Global Healthy Living Foundation, discusses the challenges that patients face in accessing biologic medicines.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains which products currently regulated as drugs will be transitioned to regulation as biologics by 2020.

Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses how the STRONGER Patents Act could affect biosimilars.

Ha Kung Wong, JD, partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether Congress might revisit the Biologics Price Competition and Innovation Act (BPCIA).

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains differences between follow-ons and biosimilars.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains the burden to the health system when FDA waives a single shared REMS requirement.

Paul P. Doghramji, MD, FAAFP discusses using biosimilars in practice.

Paul P. Doghramji, MD, FAAFP, discusses whether he has begun to prescribe biosimilars for patients with inflammatory bowel disease.

Ira Klein, MD, senior director of health care quality strategy for the strategic customer group at Johnson & Johnson Health Care Services, explains how biosimilars will help to control costs.

Jeff Patton, MD, president and CEO of Tennessee Oncology, discusses how biosimilars fit into the Oncology Care Model (OCM).

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why REMS programs give biosimilar and generic drug developers cause for concern.

Scott Lassman, JD, partner in Goodwin's Technology and Life Sciences Group, explains why Citizen Petitions to the FDA are so controversial among generic and biosimilar stakeholders.

Mark Fendrick, MD, discusses the role that biosimilars will play in value-based insurance design (VBID).

Kashyap Patel, MD, medical oncologist at Carolina Blood and Cancer Care, discusses the value that biosimilars bring to the health system.

Robert Cerwinski, JD, partner at Goodwin, explains the differences between European and US patent challenges for biologics.

Angus Worthing, MD, FACR, FACP, describes policy changes that are needed in the biosimilars space.

Robert Cerwinski, JD, partner at Goodwin, discusses the challenges that reference product sponsors encounter when they also seek to develop biosimilars.

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses major regulatory and policy differences between the European Union and the United States.

Angus Worthing, MD, FACR, FACP, clarifies key biosimilars terms.

Ha Kung Wong, JD, Partner at Fitzpatrick, Cella, Harper and Scinto, discusses whether patent litigation could deter drug makers from developing biosimilars.

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses current FDA guidance on the naming and labeling of biosimilar treatments.

Angus Worthing, MD, FACR, FACP, discusses the benefits of biosimilar medicines.

Amanda Forys, MSPH, discusses the critical lack of clarity in the US biosimilars marketplace.

Amanda Forys, MSPH, senior director of reimbursement policy insights at Xcenda, discusses current reimbursement policy for biosimilars.

Molly Burich, MS, associate director of public policy: biosimilars, pipeline, and reimbursement at Boehringer Ingelheim, discusses the challenges the industry faces with respect biosimilars.

Angus Worthing, MD, FACR, FACP, discusses the need for adequate funding for the FDA and healthcare.

Robert Cerwinski, JD, partner at Goodwin, explains why Hatch-Waxman litigation may provide a smoother path than does the Biologics Price Competition and Innovation Act.