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Health Canada Issues Guidance on BCS-Based Biowaiver

In late May, Health Canada released a final guidance document on its “Biopharmaceutics Classification System (BCS) Based Biowaivers.” The guidance is intended to inform industry on when biowaivers may be obtained.

FDA Finalizes Guidance on Interpreting Sameness of MAbs Under Orphan Drug Regs

In late April, FDA released a guideline on how to interpret “sameness” in the molecular structure of MAb products, antibody conjugates, fusion protein products, and bio-specific antibodies. The guideline was released as a draft in 1999 in response to the related language used in the 1992 orphan drug regulations. The final version remains similar in […]

International Panel of Regulators Spotlights Current Biotech CMC Regulatory Problems and Convergence Pathways

The limitations, constraints and disconnects in the current CMC regulatory processes around the world are emerging into high relief as the biopharmaceutical community wrestles with how to get new medicines that fill critical healthcare gaps more rapidly to patients and how to facilitate manufacturing adjustments that better assure the quality of marketed products....

Australia to Adopt EMA Biosimilar MAb Guideline

Australia’s Therapeutic Goods Administration (TGA) announced in mid-February that it is carrying out public consultations on its adoption of the EMA 2012 guideline for biosimilar Mabs.

IPQ Monthly Update, January 2014

In focus in IPQ’s Update for January are: ● the efforts by biotech product manufacturers to get a better grip on the quality/immunogenicity relationship ● the current FDA drug compliance office priorities – including the implementation of DQSA, FDASIA and CDER reorganizing to advance quality oversight, and ● the top problem areas FDA reviewers are seeing in analytical method filings and their advice on how to avoid them....

Post-Approval Change Regulatory Burden Draws Heat at Japan Biotech CMC Strategy Forum

Industry associations have been meeting with Japanese regulators to highlight the problems they are experiencing in Japan’s process for regulating post-approval manufacturing changes, including a lack of flexibility around biotech product changes that results in most requiring prior approval as well as meetings with the agency to resolve unclear expectations....

Biotherapeutics Developers Are Wrestling with Challenges of Connecting Quality Attributes to Immunogenicity

The developers of biotherapeutics are intensifying their efforts to understand the complex relationships between the structure of their molecules and immunogenicity and to expand the predictive power of their CMC toolbox. However, there is also a growing recognition of the long-term nature of the project and the difficulties in validating the quality analytical tools against the less than solid ground of immunogenicity assessments in the clinic....

ASEAN Adopting QbD Approach to Process Validation Under Singapore Leadership

Singapore is leading an effort by the Association of Southeast Asian Nations (ASEAN) to achieve a harmonized approach to process validation modeled on FDA’s lifecycle approach and the ICH Q8-10 paradigm it embodies....

EMA Guidelines on Process Validation Filings for Biotech Substances and Drug Products Advancing Along with GMP Annex 15 Revision

A guideline on what the European Medicines Agency (EMA) wants to see in marketing authorization applications (MAAs) regarding process validation for biotech drug substances is advancing as a third prong in the agency’s effort to strengthen its PV guidance portfolio....

Better Glycosylation Understanding Would Further International Biotech Regulatory Convergence Efforts, CMC Strategy Forum Participants Agree

Regulators are highlighting a better understanding of protein glycosylation – its linkage to product safety and efficacy and what constitutes appropriate characterization – as an important element in developing a more internationally-aligned approach to regulating biotech products....
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