This has been a very exciting time for those in drug discovery, while it’s been a bit quieter on the biosimilar front (understandably). That said, I’ve come across a few tidbits of knowledge here and there about the impact this pandemic may or may not yet be having on the biosimilar space.
- 3 Pressing Questions From The FDA/FTC Biologics Competition Workshop
- Analyzing FDA's Final Q&A Guidance On Transition Biologics
- The 4 Stages Of Drug Delivery Device Evolution: An Inhaler Case Study
- Shifting Site Of Care For Infused Drugs: An Opportunity For Biosimilars
- How Biosimilars, Biobetters Fit Into Value-Based Healthcare
- FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers
- How Can Hospitals Lead The Biosimilar Charge?
Shifting Site Of Care For Infused Drugs: An Opportunity For Biosimilars
An emerging target for payers is how IV drugs are distributed to providers and where these products are administered. Site of care strategies can generate cost savings, but they may also create unintended consequences. However, just as biosimilars have disrupted the status quo of the biologics market, they may also find opportunity in impacting how care is delivered.
FDA FY2019 Warning Letters: A Closer Look At Drug Manufacturers
Part two of this series takes a deep dive into the types of drug manufacturers that received warning letters and their locations, including data on how frequently the FDA recommends that firms hire qualified consultants and its request for “independent assessments” in warning letters.
U.S. Sites Play Surprise Role In FDA’s Drug GMP Warning Letter Report
Fiscal year 2019 was a fascinating year for drug GMP warning letters in the diversity of topics addressed, depth of focus, and trends in enforcement actions. This article presents a comprehensive summary of the drug GMP warning letters issued in FY2019, including an evaluation of trends since FY2013.
FDA’s Drug Shortages Root Cause Report: Does It Miss The Mark?
At the behest of Congress, an inter-agency Drug Shortage Task Force, led by the FDA, published the "Drug Shortages: Root Causes and Potential Solutions" report. The very first root causes listed in the report are “economic forces,” but there's a lot more to the story.
The 10 Most-Cited MHRA GMP Inspection Deficiencies By Annex/Chapter
This is the second article in a two-part series reviewing the MHRA’s publication of the GMP deficiencies for drug product published in October 2019. Part 1 identified and evaluated the critical and major deficiencies. Part 2 presents the 10 most frequently cited paragraphs for the 10 chapters and annexes with the most frequently cited deficiencies.
Biosimilar Litigation Review: Anticompetitive Conduct Cases & Post-Grant Patent Challenges
This is the fourth article in a four-part series on 2019 legal developments related to the biosimilar sector. In this final installment, we cover 2019 biosimilar litigation related to anticompetitive conduct and post-grant patent challenges at the Patent Trial and Appeal Board (PTAB), and look ahead to what biosimilar developers can anticipate in 2020.
Biosimilar Litigation Review: BPCIA Federal Circuit Appeals Pending & Recently Decided
This is the third article in a four-part series on 2019 legal developments related to the biosimilar sector. Part 1 shared statistics regarding BPCIA district court litigation and reviewed ongoing BPCIA district court cases. Part 2 covered BPCIA district court cases that were settled in 2019. Here in Part 3, we review BPCIA Federal Circuit appeals that are pending and those that were recently decided.
BIOSIMILAR WHITE PAPERS
Utilizing External Collaboration To Accelerate Vaccine Development
Securing a partner to serve as an extension of Janssen’s Biotherapeutics Development API-Large Molecule team was essential to reduce both risk and the time needed for delivery of clinical supplies.
Scaling A mAb Production Process To A Single-Use Platform
The transfer of mAb production processes between scales, referred to as scale-up or scale-down, is difficult. This study reviews moving mAb production from a microscale bioreactor to a single-use platform.
Optimizing Process Efficiency In Upstream Manufacturing
Increasing the integration of upstream and downstream processing and moving toward increased automation results in greater optimization of process efficiency — a key goal for biopharma production.
The Use Of Cell-Free Synthesis In The Future Of Modern Medicine
Cell-free synthesis systems are well suited to manufacture at the point of treatment, yet there are several challenges transitioning to this more efficient model for the future of medicine.
Development Pathways For ATMPs: Virus Safety Challenges And Regulatory Perspective
There is an increased risk of viral contamination in settings where ATMPs are prepared, making it critical to understand the contamination risks and the solutions available to control them.
Increasing Productivity In Hydrophobic Interaction Chromatography (HIC) Using Capto Resins
Downstream processes for biomolecule purification are becoming more complex. Challenges include increasing titers from upstream cell culture, greater diversity of target molecules, and a need for better productivity. HIC has characteristics designed to solve these challenges. In this study, the hydrophobicities of newer generation Capto HIC resins were compared to Sepharose High Performance and Sepharose Fast Flow HIC resins.
BIOSIMILAR DEVELOPMENT CONTENT COLLECTIONS
In line with a Congressional directive, the FDA must transition products previously approved as drugs under the Federal Food, Drug, and Cosmetic Act (FD&C Act) to biologics under the Public Health Service Act (PHS Act) by March 23, 2020. This collection of articles examines the upcoming regulatory transition in depth, sharing industry and patient perspectives on the changing regulatory requirements and market access strategies and concerns for this critical class of medicines.More Content Collections
LIFE SCIENCE EVENTS
The Dietary Supplement cGMP rule (21 CFR part 111)
March 31, 2020
Is it Method Verification or Validation, or Just Semantics
March 31, 2020
Drug Master Files: Understanding and Meeting your Regulatory and Processing Responsibilities
March 31, 2020
Design History File (Design History File), the Device Master Record (DMR) and the Device History Record (Device History Record) - Principles of Lean D
March 31, 2020
Metrology: Statistical Analysis of Measurement Uncertainty
April 1, 2020