Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

In March 2010, as part of Affordable Care Act, Congress passed a well-conceived and critical legislative bill, the Biologic Pricing and Competition Innovation Act of 2009 (BPCIA)i. Despite its intentions, BPCIA has been instituted so that it complicates prescribing while increasing health care costs and reducing competition, rather than resulting in the anticipated benefits.

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Byline

Howard S. Hochster, MD

Distinguished Professor of Medicine; Associate director for clinical research and director, GI Oncology; Rutgers Cancer Institute; Director of oncology research, RWJBarnabas Health

Michael P. Kane, RPh, BCOP

Executive director, Oncology Pharmacy Services & Research Shared Resource, Rutgers Cancer Institute

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Regulatory News

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As he addressed FDA employees, HHS Secretary Robert F. Kennedy Jr. described the Trump era as a “generational opportunity to make the regulatory agency live up to its foundational ideals” and emerge from the morass of what he described as the “deep state.”

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

FDA on April 11 approved nivolumab (Opdivo) with ipilimumab (Yervoy) for the first-line treatment of adult patients with unresectable or metastatic hepatocellular carcinoma.

April 18, 2025

Vol.51 No.15

Drugs & Targets

FDA to phase out animal testing requirement for monoclonal antibodies, other drugs

FDA announced on April 10 its efforts to advance public health by replacing animal testing in the development of monoclonal antibody therapies and other drugs with more effective, human-relevant methods.

April 18, 2025

Vol.51 No.15

Cancer Policy

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

A federal judge ruled that the FDA lacks the statutory authority to regulate laboratory developed tests, finding squarely in favor of plaintiffs in the consolidated lawsuits brought by American Clinical Laboratories Association, Association for Molecular Pathology, and others. ASCP submitted an amicus brief supporting the plaintiffs.

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Drugs & Targets

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA granted full approval for Vitrakvi (larotrectinib), a first-in-class TRK inhibitor for the treatment of adult and pediatric patients with solid tumors that have a neurotrophic receptor tyrosine kinase gene fusion without a known acquired resistance mutation, are metastatic or where surgical resection is likely to result in severe morbidity, and have no satisfactory alternative treatments or that have progressed following treatment.

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Vol.51 No.14

Drugs & Targets

FDA approves Jobevne, a bevacizumab biosimilar

FDA approved Biocon Biologics Ltd’s Jobevne (bevacizumab-nwgd), a biosimilar bevacizumab for intravenous use. Jobevne, a recombinant humanized monoclonal antibody used to treat several different types of cancer, is a biosimilar to the reference product Avastin (bevacizumab).

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Vol.51 No.14

Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

YOU MAY BE INTERESTED IN

RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”
Whistleblowers will be “honored”

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

FDA to phase out animal testing requirement for monoclonal antibodies, other drugs

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA approves Jobevne, a bevacizumab biosimilar

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Annals of Unintended Consequences: How FDA regulations undermine the biosimilar marketplace and the BPCIA

YOU MAY BE INTERESTED IN

RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”Whistleblowers will be “honored”

FDA approves nivolumab + ipilimumab for unresectable or metastatic HCC

FDA to phase out animal testing requirement for monoclonal antibodies, other drugs

Federal judge nixes FDA’s LDT rule, says agency exceeded its authority

FDA approves Vitrakvi for NTRK gene fusion-positive solid tumors

FDA approves Jobevne, a bevacizumab biosimilar

Never miss an issue!

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RFK Jr. urges FDA staff to resist “agency capture” by special interests and resist “deep state”
Whistleblowers will be “honored”