Latest News – Safe Biologics

New ASBM Infographic Tells Congress: “Proceed with Caution; Patients at Risk”

September 2, 2026

ASBM has released a new fact sheet explaining the risks posed by the Biosimilar Red Tape Elimination Act (BRTEA, S. 1954). Today, FDA evaluates each biosimilar individually before determining whether it is interchangeable—meaning it may be substituted at the pharmacy without the prescribing physician’s approval. BRTEA would eliminate that product-by-product scientific review and automatically deem […]

ASBM Supports Bipartisan SUSTAIN 340B Act

August 6, 2026

August 6, 2026 – ARLINGTON, VA The Alliance for Safe Biologic Medicines (ASBM) commends Senators Jerry Moran (R-KS), Tammy Baldwin (D-WI), Shelley Moore Capito (R-WV), Tim Kaine (D-VA), John Boozman (R-AR), and John Hickenlooper (D-CO) for introducing the bipartisan Supporting Underserved and Strengthening Transparency, Accountability, and Integrity Now and for the Future of 340B Act, […]

Andrew Spiegel and Marcia Horn: MFN Could Cost Patients Cancer Breakthroughs

June 24, 2026

When Congress Tries to Overrule Biology

June 18, 2026

By Peter J. PittsJune 16, 2026 Read the full article at RealClearHealth One of the first things I learned during my time at the FDA was that biology rarely cooperates with political talking points. That’s not a criticism. It’s simply reality. Biological medicines are complicated. Patients are complicated. Scientific evidence is often complicated. Anyone looking for […]

ASBM Statement on Senate HELP Committee Passage of Biosimilar Red Tape Elimination Act

June 17, 2026

Statement of the Alliance for Safe Biologic Medicines on Senate HELP Committee Passage of the Biosimilar Red Tape Elimination Act (S. 1954)June 17, 2026 The Alliance for Safe Biologic Medicines (ASBM) is deeply disappointed that the Senate HELP Committee today advanced the Biosimilar Red Tape Elimination Act (S. 1954). S. 1954 does not eliminate red […]

ASBM Urges CO PDAB to Reject Upper Payment Limits Without Patient Protections

May 19, 2026

On May 15, ASBM submitted comments to the Colorado Prescription Drug Affordability Board urging it not to impose an upper payment limit (UPL) on Cosentyx unless the Board can demonstrate that the policy will directly reduce patient out-of-pocket costs without disrupting access to treatment. ASBM emphasized that a UPL would reduce the amount paid by […]

ASBM Submits Comments to FDA on Biosimilar Draft Guidance

May 15, 2026

On May 11th, ASBM submitted comments on the FDA’s recently released draft guidance and Q&As aimed at “streamlining” biosimilar development by permitting the use of data from non-U.S.-licensed comparator products and foreign clinical studies in the U.S. biosimilar approval process. While efficiency is important, ASBM is concerned that these changes may lower evidentiary standards in […]

Take Action: Support the MINI Act to Protect Patient Access to Genetic Therapies

May 9, 2026

Congress is considering the Maintaining Investments in New Innovation Act (MINI Act) [HR 1672], legislation to protect patient access to genetically targeted therapies (GTTs)—innovative treatments designed to address the underlying genetic causes of serious diseases. Under current law, some of these therapies may face Medicare price controls earlier than similarly complex treatments, simply due to […]

Tell Congress: Support the SAFE Drugs Act

April 16, 2026

ASBM is urging Congress to pass the SAFE Drugs Act of 2026, legislation designed to strengthen oversight of unsafe, unapproved, and mass-marketed copycat medicines. Pharmacy compounding plays an important and legitimate role in patient care when FDA-approved therapies are unavailable or when a patient has a specific clinical need that cannot be met by an […]

CO Bills Address Compounding Risks and Patient Safety

April 12, 2026

ASBM recently engaged on two bills in Colorado addressing oversight of drug compounding and patient safety. The organization supports SB 26-130, which adds targeted safeguards for med spas and other settings handling prescription drugs, helping ensure that these products are stored, handled, and administered safely. At the same time, ASBM opposes HB 26-1262, which would […]