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FDA Finalizes Guidance About Delaying, Denying, Limiting, Or Refusing An Inspection
The FDA has finalized a guidance on the circumstances that constitute delaying, denying, limiting, or refusing a drug or device inspection. The agency also provides reasons that may cause drugs or devices to be adulterated under the FD&C Act.
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Bacterial Endotoxin Testing, Part 1: Overview
All injectable drug products and implantable medical devices that come into contact with the bloodstream or spinal fluid are tested for endotoxins. This article provides an overview of bacterial endotoxin testing and the LAL method.
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Derisking Biomanufacturing: Why A CDMO In Poland Might Be Your Secret Weapon
The current geopolitical climate is leading drug developers to consider global manufacturing partnerships strategically. Identify a CDMO partner that will help protect your IP, save money, and mitigate risk.
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How Recent Trends Impact Bringing Your Molecule To Market
With accelerated approval times, growing competition between drugs, and a shift from hospital to home care, you’re under pressure to develop a delivery device in parallel with your drug.
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A Practical Packaging Components Checklist For Emerging Biotechs
A proactive approach to packaging development can ultimately ensure a smoother launch. Explore five key considerations in selection components for your injectable drug product.
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Lifecycle Planning For Containment And Delivery Of Biologics Drug Products
Read more about trends in the biologics market that could impact the lifecycle strategies for your drug product and steps you can take around drug packaging early in development to set yourself up for future success.
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What Does FDA's Draft Platform Guidance Mean For CGT Companies?
Details of the FDA's highly-anticipated platform technology program were released in the form of a draft guidance. Let's explore with a former FDA/CBER regulator.
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Revolutionizing Drug Discovery: The Rise Of Fashionable Models
As a result of advancements in research technology, "fashionable models" such as organoids and organs-on-chips (OoCs) have been developed. Explore organoid and OoC technologies in detail.
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AI Integration In Drug Manufacturing: GMP Insights For Operational Excellence, Regulatory Compliance
This article provides insights into a variety of use cases on the application of AI/ML in GMP settings and 5 key considerations for drug manufacturers using AI.
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Is Your Intellectual Property Safe With Indian CROs And CDMOs?
Startups and Big Pharma companies alike are considering India as an alternative to working with China. Is it safe to do business with India? Let's do a deep dive, with insights from American and Indian attorneys.
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EMA Updates Guidance On Inhalation And Nasal Product Quality
The EMA has issued a new draft guideline, “Guideline On The Pharmaceutical Quality Of Inhalation And Nasal Medicinal Products.” The public comment period ends Oct. 31.
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A Synergy Of Excellence: Partnership During Unprecedented Times
Learn how a partner with the right experience and capabilities is crucial to support accelerated GMP manufacturing and ensure novel vaccines and therapeutics receive regulatory approval.
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Quick Read: FDA's New Draft Guidance On Data Integrity For In Vivo BA/BE Studies
The FDA has released a draft guidance, Data Integrity for In Vivo Bioavailability and Bioequivalence Studies. This article shares a concise summary. The FDA is accepting public comments through June 3.
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New FDA Draft Guidance: Data Integrity For In Vivo Bioavailability And Bioequivalence Studies
The FDA's new draft guidance emphasizes maintaining data integrity throughout bioavailability/bioequivalence studies and provides recommendations for applicants and testing site management. The public comment period ends July 3.
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Nitrosamines: New WHO Guidance Provides Expanded Risk Assessment Considerations
Nitrosamines are potential contaminants of drug products. Contamination can occur from synthesizing APIs and excipients, from leaching into the product from primary packaging, and more.
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Strategies For Ensuring Virus Bank Manufacturing Success
Learn about the processes and best practices applied at a GMP facility to optimize the production of working virus seed stocks and master virus seed stocks.
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Integrating Quality Processes And Documentation After A Merger
If your company is undergoing a merger, you must juggle operations while ensuring minimal disruptions. You'll need a holistic view of QMS and SOPs to harmonize procedures.
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5 Areas To Focus Your QRM Strategy For Sterile Drug Products
Explore five areas that can form part of a quality risk management strategy to ensure the compliant manufacturing of sterile drug products.
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Single Use In Biopharma: Beyond Savings & Sustainability
SUT continues to trend in biopharmaceutical applications, driven largely by environmental and economic considerations. But there’s a lot more to the SUT story, including supply chain and standardization advantages. We dove headlong into those issues and more with independent SUT expert Paul Priebe and Krystal Biotech VP of Technical Operations Mark Petrich.
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Tips For Viral Vector Production
Learn about how meticulous purification optimization can maximize recovery and impurity removal by leveraging scalable downstream technologies to meet regulatory and process economy requirements.
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FDA Publishes Final Guidance On Reporting Listed Drug Amounts
Despite earlier efforts to shore up the U.S. drug supply chain, COVID-19 still brought shortages. A new FDA reporting system aims to reduce future supply risks.
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Quick Takes From Takeda Austria's Annex 1 Rollout
At ISPE's 2024 Aseptic Conference, Takeda Austria's site head spoke about lessons learned from Annex 1 implementation. We caught up with her and asked for the highlights.
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Navigating Grades And Sources Of Materials In Drug Manufacturing
From raw materials to finished dosage forms, understanding material quality is essential in drug manufacturing. This article examines how material grades and sources guide selection for optimal safety and functionality.
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Fine-tuning Analytical Development Strategies For Every Phase
Analytical challenges morph phase-by-phase during drug development. Three Novartis scientists describe a platform approach based on guidance from the ICH and USP.
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Top 10 Biologics Approved In 2023
In 2023, 18 new biologic drugs were approved by the EMA and 34 by the FDA. Dive into the 10 most important drugs that cover unmet medical needs and have the potential to revolutionize medical practice.
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A Structured Approach To Regulatory Information Management Vendor Selection
Deploying a formal system for regulatory information management is a given now for all life sciences companies, irrespective of their size and focus. Regulators expect this, particularly as data rather than static documents evolves to become the default.
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Navigating China's Biologics Approval And Accelerated Pathways
Pharma companies doing business in China have four key routes to register drugs faster than the standard ways. This discussion breaks down accelerated pathways and offers tips on how to approach them.
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Understanding And Navigating Diverse Regulatory Environments
Drug developers aspire to treat patients globally, but navigating diverse regulatory structures around the world gets tricky. These consultants offer a primer on the regulatory bodies of the world.
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New DSCSA Guidance Details Layers Of Verification System Requirements
A recent FDA final guidance interpreting the DSCSA details verification systems expectations for trading partners. Just how they should meet these expectations, however, remains unclear.
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Trends In FDA FY2023 Inspection-Based Warning Letters
The U.S. FDA issued 180 warning letters to drug and biologics manufacturers in fiscal year 2023 (FY23) and 94 of them were based on an on-site inspection of the company. This article provides an analysis of trends and observations from the inspection-based letters, as well as additional insight on the agency’s approach to enforcement.
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
- Sandoz Launches Biosimilar Pyzchiva® (ustekinumab) Across Europe, To Treat Chronic Inflammatory Diseases
- Kashiv BioSciences Announces Completion Of Enrollment For Phase III Clinical Trial Of ADL018, A Biosimilar Candidate To XOLAIR (Omalizumab)
- Bio-Thera Solutions Initiates Integrated Phase I / Phase III Clinical Trial For BAT3306, A Proposed Biosimilar Of Keytruda® (Pembrolizumab)
- Bio-Thera Solutions Announces Regulatory Filing Acceptance For BAT2206, A Proposed Biosimilar To Stelara® In The US And EU
- FDA Approves Samsung Bioepis' EPYSQLI® (eculizumab-aagh) As A Biosimilar To Soliris (eculizumab)
- STADA And Alvotech Launch Uzpruvo, The First Approved ustekinumab Biosimilar To Stelara, Across Europe
- Boehringer Ingelheim And GoodRx Announce Exclusive Patient Affordability Initiative For Adalimumab-adbm Injection, Boehringer's Biosimilar To Humira®
- Xbrane Provides Update On Its Development Portfolio