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An overview of the key regulatory intelligence updates from FDA & EMA released in 2025.
FDA’s draft guidance streamlines biosimilar approval by reducing the need for comparative efficacy studies (CES). The guidance provides revised criteria outlining the circumstances in which conducting CES may be unnecessary for a Biologics License Application submitted through the 351(k) biosimilar and interchangeable biosimilar pathway.
This November, Scendea had the pleasure of attending BIO-Europe Autumn 2025 in Vienna, Austria. The focus of BIO-Europe Autumn 2025 was gene therapy, precision medicine, funding strategies and challenges across the industry.
When market protection ends, it triggers a shift in the competitive landscape for a product and often has a significant effect on the originator company which can see an overnight loss in revenue and potential biosimilar manufacturers. There are generally two types of market protection.
Eight CAR-T products have been approved in the US thus far, and CAR-T products account for approximately 55% of all Gene Therapy INDs. A combination of factors, including manufacturing challenges, clinical development timelines and differences in regional regulatory requirements, complicate the development of CAR-T products.
The 8th annual symposium for Life Science Innovation and Development was a day packed with timely topics for small and emerging biotech companies. As the welcome meeting highlighted, “With private investment still stalled and changes in federal funding along with tariffs and job reductions, the challenges for the industry have never been more serious”.
The FDA has announced a new review process for rare
diseases based on a molecule’s “plausible mechanism”
which would allow the FDA to consider approval on a conditional basis. This initiative is designed to help speed up the approval of drugs to treat rare diseases and provide clear guidance on how evidence of efficacy can be demonstrated with a small patient population.
A prefilled syringe (PFS) is a disposable syringe that comes preloaded with a specific dose of medication, ready for injection. This design simplifies the process of administering injectable drugs, as it eliminates the need to draw medication from a vial into a syringe before use.
Vaccines are defined as medicinal products intended for prevention, post-exposure prophylaxis and/or treatment of disease caused by an infectious agent and which contain antigen(s) or genetic information for an antigen(s), either of biological or synthetic nature, that induce a specific immune response against the causative infectious agent(s) or its toxins (EMA 2023).
On the 17th of June 2025 the FDA Commissioner Marty Makary announced a new initiative aimed at enhancing the health interests of the United States (US) population. The Commissioner’s National Priority Voucher (CNPV) will be granted to US companies developing drugs that are: Addressing a health crisis in the US, Delivering more innovative cures for the American people, Addressing unmet public health needs, Increasing domestic drug manufacturing as a national security issue.
Biotech companies, who are looking to secure investment to enable development of their medicinal products, must navigate a competitive funding landscape while optimizing their fundraising strategies. To de-risk and support fundraising strategies globally it’s imperative that product development and regulatory strategy are carefully considered and enacted upon.
In August 2024, the US Food and Drug Administration (FDA) released new guidance for the Project Optimus initiative, titled “Optimizing the Dosage of Human Prescription Drugs and Biological Products for the Treatment of Oncologic Diseases”.
Antimicrobial resistance (AMR) poses such a
significant threat to global public health that it now necessitates urgent action to accelerate the development of new antibiotics. Currently, most research into new antimicrobials is conducted by academia and start-up companies. Whilst the focus appears to remain on traditional small molecule therapeutics, novel approaches have gained attention across biologics, bacteriophages, and microbiome projects.
In April 2025, the US Food and Drug Administration (FDA) announced their plan to phase out animal testing and instead favour more effective, human-relevant methods – namely “New Approach Methodologies” (NAMs).
Before entering clinical trials in humans, new drugs and devices must undergo nonclinical testing to evaluate their safety and efficacy. There is no fixed roadmap for nonclinical studies required for such assessments – regulatory authorities assess applications in a case-by-case manner – however, traditional approaches are outlined in FDA, EMA and ICH guidance documents.
The drug discovery and development process that takes a chemical compound from initial lead selection to preclinical evaluation and ultimately the clinic is not necessarily a
linear one.
Discover why Australia is a leading destination for clinical trials. In this webinar, Scendea and our partners explore the key advantages, including expedited regulatory approvals, cost efficiencies, and access to top-tier facilities and expertise.
The FDA accelerated approval pathway was established in 1992 (FDA, 1992) to expedite access to new therapies for patients with serious or life-threatening diseases. First created to rapidly address unmet medical need during the HIV-AIDS crisis, oncology drugs now comprise the largest proportion of accelerated approvals (Sachs et al., 2021).
An overview of the key regulatory intelligence updates from FDA, EC, EMA & MHRA released in 2024.
The evolution of the regulatory landscape for biopharmaceutical and advanced therapy companies demands a focus on aligning innovative technologies, such as platform methods and advanced manufacturing, with the expectations of regulatory agencies.
Pulmonary drug delivery has been primarily the delivery of choice for the treatment of local conditions or diseases active in the respiratory tract for over 70 years. For local activities, inhaled drugs are delivered directly to the site of action in the lung, providing fast onset of action.
