-
FDA Issues Draft Guidance On The Use Of AI To Support Regulatory Decision-Making For Drug And Biological Products
The U.S. FDA issued a draft guidance, Considerations for the Use of Artificial Intelligence to Support Regulatory Decision-Making for Drug and Biological Products, on January 6, 2025. The public comment period ends April 7.
-
Ensuring Repeatable, Viable Surface Sampling In Aseptic Settings
Without high quality data, surface sampling simply becomes another exercise in checking regulatory compliance boxes.
-
Clinical Regulatory Changes One Of Many Tailwinds For Biosimilars
With an projected global market value of $35.7 billion in 2025, biosimilars are slated for considerable growth opportunities, thanks in part to clinical regulatory changes.
-
These Were FDA's Top Citation Issues For Data Quality In 2024
Pharma, biopharma, and medical device makers should watch out for these perennial problems, which include inadequate procedural controls and poor record-keeping.
-
2024 Trends In FDA Observations For Sterile Drug Manufacturers
This data-driven analysis of the 2024 trends in FDA observations for sterile drug manufacturers includes a comparison to the 2023 trends. Which 21 CFR 211 sections surprise you most?
-
Top 10 Data Auditor Statistical Software Requests
Statistical analysis provides a backbone for establishing critical process parameters and offers evidence of process validation for regulatory submissions.
-
New Regulatory Survey Findings: Biotech Global Market Access Challenges And Learnings
To understand biotech companies’ evolving geographic strategies and perceptions, Arriello recently commissioned a transatlantic survey among regulatory, safety, and quality directors at small/medium biotechs, with respondents in Ireland and North America.
-
Keep An Eye On These Analytical And Monitoring Trends In 2025
Three experts share their thoughts on the advances and obstacles in analytical development that they're thinking about as we head into 2025.
-
Survey Findings: How Are IDMP Readiness Efforts Progressing?
ISO Identification of Medicinal Products (IDMP) standards were designed to harmonize the way the life sciences industry records and manages data about its products. Companies’ state of readiness to implement and harness IDMP still varies.
-
Software Simplifies 21 CFR Part 11 and Annex 11 Compliance
21 CFR Part 11 and Annex 11 regulate electronic records and signatures in biomanufacturing, ensuring data integrity, security, and compliance while enabling efficient processes and regulatory alignment.
-
Improving Bioprocess Monitoring And Control With Multivariate Data Analysis
Learn about multivariate data analysis (MVDA) techniques, like PCA and PLS, that enable near real-time monitoring, prediction, and optimization of biomanufacturing processes.
-
Continued Process Verification: Driving Consistent Quality In Manufacturing
Continued process verification (CPV) ensures pharmaceutical processes remain controlled by monitoring key parameters, detecting variations, and maintaining product quality.
-
Guide To PUPSIT And Annex 1 In Aseptic Processing
Pre-use, post-sterilization integrity testing (PUPSIT) ensures filters remain undamaged and effective during aseptic manufacturing. Discover how you can successfully perform PUPSIT with proven solutions.
-
Is The BIOSECURE Act The First Real Step Toward Reshoring?
The U.S. pharma industry has relied heavily on China and India to produce regulatory starting materials and APIs. The BIOSECURE Act has now emerged. Is this the first real step toward reshoring?
-
Integrated Approach In Managing CPV And APQR
Many companies continue to manually collect data. Utilizing digital technologies can greatly improve productivity and efficiency by enabling real-time monitoring and streamlining regulatory reporting.
-
A Risk-Based Approach To Filter Integrity Testing Annex 1 Requirements For Biologics DS
How do the principles of filter integrity testing described in EudraLex Annex 1 apply to low bioburden drug substance manufacturing? And how can using a risk-based approach help?
-
Choose The Right CDMO To Guide Your Biologic To Regulatory Success
If you are wondering when to begin your CDMO search, the answer is simple: the sooner the better. Partnering with a CDMO early helps ensure later success.
-
Aligning Sterile Filtration With EU GMP Guide Annex 1 Standards
A recent chapter by GMP Compliance Adviser explores sterile filtration including filter qualification, process validation, and integrity testing through an Annex 1 lens.
-
Safety Cabinets' Essential Role In EU GMP Annex 1
A new chapter by GMP Compliance Adviser explores safety cabinet classifications and applications, plus requirements for their construction and and installation, per Annex 1.
-
What's Next After FDA's DSCSA Extension?
Facing growing pressure from industry and Congress, FDA extended its enforcement deadline yet again, which has important implications for manufacturers.
-
Data Quality Issues At The Heart Of FDA's DSCSA Troubles
Industry still struggles to manage complex data requirements, which forced the FDA to once again delay enforcement of the Drug Supply Chain Security Act.
-
CDER Wants Your Input On Improving Integrated Reviews
CDER recently moved from sharing reviews from individual disciplines in public documents to an Integrated Review, which includes conclusions but much less detail.
-
A Supplier-Manufacturer Approach To Mitigating Nitrosamine Risk
Learn about how nitrosamines are formed, their prevalence and chemical precursors in pharmaceuticals, techniques for quantification, and approaches for managing nitrite impurities.
-
The Regulatory Affairs Function Is Evolving. Are You Evolving With It?
The regulatory affairs function is no longer a "one size fits all" function, the decision to outsource or insource the function is growing more complex, and specific AI tools can help regulatory processes.
-
A Risk-Based Approach To Validation Studies For Sterilizing-Grade Filtration And Single-Use Systems
One way to address risk related to product quality is by implementing a Question-Based Review approach. Read on to learn about this approach and its advantages.
-
What To Do When Your Regulatory Findings Need Quality Risk Management Action
More than half of all recent warning letters issued by the FDA include citations for absent or incomplete risk assessments. This article examines what regulators are looking for.
-
A Robust Extractables Data Package Helps Drive Patient Safety
Complex drug product formulations are more common, so it is imperative to have a deeper knowledge of extractables to understand risks associated with potential interactions between packaging and product.
-
FDA Issues Revised Guidance On Controlling Nitrosamine Impurities In Pharmaceuticals
The FDA has issued a revised version of its guidance, Control of Nitrosamine Impurities in Human Drugs. This article explores the agency's recommendations, root causes of nitrosamines, and strategies for mitigating their presence in pharmaceuticals.
-
PUPSIT As Part Of A Contamination Control Strategy (CCS)
Learn about the changes introduced in the latest revision to EU GMP Annex 1, and gain insight into the components that should be part of a PUPSIT risk assessment.
-
When Should Filter Validation Be Performed?
Learn about a program that has been developed to facilitate risk mitigation before process-specific filter validation is performed.
ABOUT BIOSIMILAR REGULATIONS
The first biosimilar was approved for the European market in 2006. While the regulatory pathway for biosimilars in the U.S. was created as part of the Affordable Care Act in March 2010, the first biosimilar was only recently approved for the U.S. market in March 2015.
Biosimilars are essentially generic versions of large molecule biologics. However, the fact they are not exact copies of the reference product makes establishing regulations for their approval and release to market a more complicated process. The WHO, along with many other parties in the pharmaceutical industry, has argued that regulations governing the development and approval of small molecule generics are not appropriate for more complex biological medicines. As such, the WHO set out to establish regulations articulating the efficacy, safety, and quality standards biosimilars must meet and maintain to make it to market. These regulations specify that a biosimilar must prove its biosimilarity to a reference product through head-to-head comparisons. The biosimilar company must also submit non-clinical and clinical studies data and a pharmacovigilance plan to the appropriate regulatory body. Those navigating the landscape of current biosimilars regulations face the challenge of demonstrating a biosimilar’s safety, purity, efficacy, and potency.
The current U.S. Food and Drug Association (FDA) and European Medicines Agency (EMA) regulations for biosimilars require these biologic copies to undergo extensive analytical chemistry, manufacturing, and control (CMC) and clinical processes to prove similarity to the reference product. However, in comparison to the originator biologic, a biosimilar could see an accelerated approval process, as it might need less data to meet the established regulations. The EMA was the first regulatory authority to establish marketing regulations for biosimilars in 2005. Other countries including Australia, Canada, Japan, Korea, and South Africa have since turned to the EMA’s regulations, as well as the WHO’s regulations, as a model for crafting their own regulations. In 2012, the FDA released three draft guidances to assist biosimilar developers in demonstrating their product’s biosimilarity. To comply with existing U.S. regulations, manufacturers are expected to include structural analysis, functional assays, and data from animal and human clinical trials in their applications. As biosimilar production spreads globally, regulations have continued to shift and evolve. Currently, each governing body has differing definitions/terminology for biosimilars, and as such, has established varying regulations dictating what studies and data are needed to be approved for the market.
BIOSIMILAR DEVELOPMENT NEWS
- Phase 3 MRCT Results Of Denosumab Biosimilar HLX14 Released At ORS 2025
- Bio-Thera Solutions Announces Exclusive Commercialization And License Agreement With Intas Pharmaceuticals For BAT2506, A Proposed Biosimilar Referencing Simponi® (golimumab), In The United States Of America
- Accord BioPharma Strengthens Pipeline Through Exclusive U.S. Licensing Agreement With Bio-Thera For BAT2506, A Proposed Golimumab Biosimilar
- Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2506, A Proposed Biosimilar To Simponi®, In The European Union
- Dr. Reddy's Enters Into Collaboration With Henlius For Commercialization Of HLX15 (daratumumab), A Biosimilar Candidate To Darzalex & Darzalex Faspro In The U.S., And Europe
- US FDA Accepts Biologics License Application (BLA) For HLX11, Biosimilar Candidate Of Perjeta (pertuzumab)
- U.S. FDA Approves Celltrion's AVTOZMA® (tocilizumab-anoh), A Biosimilar To ACTEMRA®
- Kashiv Biosciences Announces Successful Phase 1 Results For Abatacept Biosimilar Candidate, KSHB002