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 […]
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 […]
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 […]
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On May 11th, ASBM submitted comments on the FDA’s recently released draft guidance and Q&As aimed at “streamlining” biosimilar development by permitting the use of data from non-U.S.-licensed comparator products and foreign clinical studies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 […]
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 […]
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 […]
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 […]
March 26, 2026
ASBM recently submitted a letter opposing California Senate Bill 1094, which would permit generic-style pharmacy-level substitution of non-interchangeable biosimilars. While biosimilars are safe and effective, they are not generics—and substitution decisions for biologics should remain grounded in evidence, physician judgment, and patient-specific considerations. California’s current framework appropriately allows substitution only for biosimilars that meet the […]
March 17, 2026
Washington Examiner (Opinion): FDA Chaos Threatens Administration’s Drug Agenda and Risks Patient Safety March 15, 2026 | Dr. Cristina Beato The Trump Administration recently celebrated one year of embracing the movement to Make America Healthy Again. Unfortunately, many of these successes are overshadowed by slapdash decision-making at a key health agency, which significantly undermines the Administration’s goals, threatens treatment […]
February 22, 2026
by Michael Reilly, ASBM Executive Director It feels impossible these days to go a single week without news of another shocking policy move from the U.S. Food and Drug Administration that upends decades-old scientific consensus or agency norms regarding clinical safety data and drug approval standards. Consider the most recent example. Earlier this month, the […]
