The Rx Recap: December 7-12

Welcome to this week’s roundup of the most insightful and impactful articles from the sister publications of Dermatology Times, all under One MJH Life Sciences. Our network brings together expert perspectives, clinical advancements, and industry updates to keep clinicians informed and ahead of the curve. From cutting-edge treatments to practice management strategies, here’s a look at the top stories shaping the field of medicine.

BioRationality: FDA Issues New Guidance on Promotional Communications for Biosimilar Products

Previously covered by The Center for Biosimilars, the FDA has issued guidance clarifying promotional practices for reference biologics, biosimilars, and interchangeable biosimilars. The guidance emphasizes accurate, balanced communications, proper product identification, and limits on comparative claims—advertising cannot suggest superiority or inferiority between biosimilars and reference products. Interchangeable and non-interchangeable biosimilars must be treated equally in safety and efficacy messaging, and promotional materials must not imply inferiority due to abbreviated licensure or minor product differences. The guidance aims to ensure scientific accuracy, maintain provider and patient confidence, and support fair competition in the biosimilars market.

FDA Plans to Review Already Approved RSV Immunizations

Reported by Contagion, the FDA informed Merck, Sanofi, and AstraZeneca that their RSV immunizations—Merck’s clesrovimab-cfor (Enflonsia) and Sanofi/AstraZeneca’s nirsevimab-alip (Beyfortus)—will undergo renewed safety data review, even though both products have already passed recent rigorous approval processes. While nirsevimab was approved in 2023 and clesrovimab earlier this year, neither has shown safety concerns. HHS officials note the FDA is “rigorously reviewing the available data” as part of its standard evaluation and may update labeling if warranted. No timeline or details have been provided regarding the review process or public access to the information.

From Ambition to Advantage: How Life Sciences Leaders Are Scaling AI

A recent PharmExec analysis highlights that while nearly half of life sciences companies spend over 20% of their commercial budgets on AI, many remain stuck in isolated pilots without achieving measurable business impact. “AI Advanced” organizations distinguish themselves by treating AI as an enterprise-wide capability, integrating it into daily operations, establishing cross-functional governance, and tying initiatives to concrete business outcomes. Key barriers to scaling include disorganized or siloed data, lack of human adoption, and insufficient strategic partnerships. Successful companies invest in comprehensive data governance, align teams on AI’s augmentative role, and collaborate with external partners who share accountability for outcomes. Emerging trends point to AI driving end-to-end automation, patient support, adaptive supply chains, and prescriptive analytics. Firms that align strategy, data, people, and partnerships are best positioned to move from experimentation to tangible commercial advantage.

What IRA Drug Prices Will Mean for PBMs, Health Plans and Patients

As Medicare’s first negotiated Part D drug prices take effect in 2026, experts say the impact on costs is far more limited and complicated than expected: although CMS secured 38%–79% list-price discounts, the negotiated “maximum fair prices” often exceed the net prices plans previously paid after rebates, prompting 1.5%–3% bid increases and pushing payers to expand utilization management, favor rebated alternatives, and lean more heavily on generics and biosimilars. Beneficiary savings will vary, according to Managed Healthcare Executive, with many high-cost patients already seeing greater benefit from the separate $2,000 out-of-pocket cap implemented in 2025, while others may face higher deductibles as insurers spread IRA-related costs. The next negotiation rounds—especially the 2027 protected-class drugs and the 2028 inclusion of Part B drugs—may have greater impact, though the 2025 “One Big Beautiful Bill Act” will exempt or delay negotiation for high-revenue orphan-designated drugs such as Keytruda and Opdivo, further complicating the long-term effects of the IRA’s pricing reforms.

FDA Approves Amneal Pharmaceuticals' Cyclosporine Ophthalmic Emulsion 0.05%

Reported by Ophthalmology Times, the FDA has approved Amneal Pharmaceuticals’ cyclosporine ophthalmic emulsion 0.05%, a generic equivalent to Allergan’s Restasis for increasing tear production in dry eye patients, marking another complex ophthalmic product added to Amneal’s expanding Affordable Medicines portfolio; the company also recently advanced an ANDA for bimatoprost ophthalmic solution 0.01% and secured FDA approval in June 2025 for prednisolone acetate ophthalmic suspension, further strengthening its presence in sterile, difficult-to-manufacture ophthalmic therapies.

Want to read more on specialty care, pharmacy, industry sciences, and more? Check out MJH Life Sciences full list of brands here.