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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Table of Contents

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Clinical Trials & Tribulations

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

At its most recent meeting, the FDA Oncologic Drugs Advisory Committee focused on perioperative clinical trials, which the agency defined as neoadjuvant phase followed by surgery and continuing with adjuvant treatment using the same experimental agent (The Cancer Letter, July 26, 2024).

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

FDA has granted an accelerated approval to afamitresgene autoleucel (Tecelra), a melanoma-associated antigen A4 (MAGE-A4)-directed genetically modified autologous T-cell immunotherapy, for adults with unresectable or metastatic synovial sarcoma who have received prior chemotherapy, are HLA-A*02:01P, -A*02:02P, -A*02:03P, or -A*02:06P positive and whose tumor expresses the MAGE-A4 antigen as determined by FDA-approved or cleared companion diagnostic devices.

August 02, 2024

Vol.50 No.31

Drugs & Targets

FDA approves Darzalex Faspro combination for MM

FDA has approved Darzalex Faspro (daratumumab and hyaluronidase-fihj) in combination with bortezomib, lenalidomid, and dexamethasone (D-VRd) for induction and consolidation in patients with newly-diagnosed multiple myeloma who are eligible for an autologous stem cell transplant.

August 02, 2024

Vol.50 No.31

Drugs & Targets

FDA approves Shield blood test for colon cancer screening

Guardant Health Inc., a precision oncology company, announced that FDA has approved the company’s Shield blood test for colorectal cancer screening in adults age 45 and older who are at average risk for the disease.

August 02, 2024

Vol.50 No.31

Drugs & Targets

FDA grants Priority Review to Scemblix for newly-diagnosed Ph+ CML-CP

FDA has granted Priority Review status to Scemblix (asciminib) for treatment of newly-diagnosed adult patients with Philadelphia chromosome-positive CML in chronic phase.

August 02, 2024

Vol.50 No.31

Drugs & Targets

Expanded access program opens in the U.S. for TLX101-CDx, Telix’s investigational glioma imaging agent

Telix opened an expanded access program in the United States for TLX101-CDx (Pixclara, 18F-floretyrosine or 18F-FET) an investigational positron emission tomography agent for imaging progressive or recurrent glioma, following FDA agreement to proceed.

August 02, 2024

Vol.50 No.31

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

YOU MAY BE INTERESTED IN

Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

FDA approves Darzalex Faspro combination for MM

FDA approves Shield blood test for colon cancer screening

FDA grants Priority Review to Scemblix for newly-diagnosed Ph+ CML-CP

Expanded access program opens in the U.S. for TLX101-CDx, Telix’s investigational glioma imaging agent

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

YOU MAY BE INTERESTED IN

Of adaptive and factorial designsA biostatistician’s interpretation of last week’s ODAC

FDA grants accelerated approval to afamitresgene autoleucel for unresectable or metastatic synovial sarcoma

FDA approves Darzalex Faspro combination for MM

FDA approves Shield blood test for colon cancer screening

FDA grants Priority Review to Scemblix for newly-diagnosed Ph+ CML-CP

Expanded access program opens in the U.S. for TLX101-CDx, Telix’s investigational glioma imaging agent

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Of adaptive and factorial designs
A biostatistician’s interpretation of last week’s ODAC