Biosimilar Drug Development, Complex Medicinal Products, Medical Device Regulations, Research and Technology and a Preview of January

Posted 04 January 2017 By Gloria Hall


The following is a summary of feature articles posted throughout December with links and a preview of what's to come in January.

Feature articles in December discussed lessons learned from biosimilar drug development, how FDA reviews and approves another group of generics generally referred to as Non-Biological Complex Drugs (NBCD) or complex medicinal products and global developments of biosimilars presented at the 2016 RAPS Regulatory convergence. Other features highlighted medical device regulations and regulatory changes worldwide, the biggest challenges of a fragmented Regulatory Information Management (RIM) landscape, diabetes and the impact of insulin discovery, requirements of payers and regulators and company strategies to ensure expedited regulatory approval, andthe steps required to prepare for the global implementation of Identification of Medicinal Products (IDMP) standards.

In their article, "Lessons Learned from Biosimilar Drug Development," Humel and Rulewski discuss the emerging US biosimilars market, including critical success factors, safety issues, extrapolation, choice of reference product, partnerships and alliance management, clinical trial recruitment and regulatory and commercial factors. The authors describe an accelerated approach to biosimilar clinical development.

With all the attention recently focused on biosimilars, it might be easy to overlook another group of generics generally referred to as Non-Biological Complex Drugs (NBCD) or complex medicinal products. In his article, "Complex Medicinal Products—the Other 'Biosimilar'," Balogh reviews how FDA and other regulatory agencies review and approve generic forms of these products.

Fillmore summarizes presentations from the 2016 RAPS Regulatory Convergence meeting held in San Jose in his article, "Global Developments of Biosimilars." Clarity emerged with respect to where the US and EU stand in terms of biosimilar product approvals, product naming, interchangeability, safety and pharmacovigilance and  biosimilar "clusters," a term referring to international groups working together on biosimilars issues.

In another summary from RAPS Regulatory Convergence, Fillmore presents medical device regulations and regulatory changes worldwide, including FDA's establishment of a national evaluation system for medical devices, China's agreement to give imported medical devices the same treatment as those manufactured or developed domestically, Japan's reduced review time for medical devices over six years, Asia/Pacific's expected medical device market expansion and Mexico's increase in device submissions.

Research and Technology

In this third installment of a three-part series, Reilly shares the results from a focus group on the biggest challenges impacting life sciences companies when trying to manage regulatory information. In his article, "Unifying Best Practices for Managing Regulatory Processes," Reilly provides the advice of industry leaders to address the challenge of fragmented Regulatory Information Management (RIM) systems and provides ways regulatory teams can create unified systems to more accurately and efficiently assess the true impact of a variation.

Although a number of so called blockbuster drugs claim to be miracles, none have yet reached the status of injectable insulin. In his article, "Insulin—the First Truly Miracle Drug," Sherman discusses diabetes, the process and discovery of insulin and provides brief biographies of two intrepid people involved.

Regulatory approval has always been the main hurdle for developers trying to bring needed new drugs to patients. Macaulay discusses the divergent evidentiary requirements of payers and regulators in his article "Bridging the Gap: Satisfying Payers in an Era of Expedited Regulatory Pathways." He presents strategies companies can employ to help bridge this gap to ensure expedited regulatory approval effectively translates into reimbursement and patient access.

Law and Legislation

Despite clear progress in the development of increasingly specific and complex drugs, health authorities worldwide say they have observed a steady and alarming increase in the occurrence of adverse drug reactions harming patients around the globe. In his article, "Identification of Medicinal Products (IDMP) Standards: Impact on the Regulatory World," Schlaps reviews the steps needed to prepare for the global implementation of the standards and offers technical solutions for the industry.

Feature Articles to Look for in January

January's collection of feature articles will focus on regulatory intelligence including a regulatory tools compendium, critical thinking skills for RI professionals, transparency and access to information in the US, EU and Canada, RI tools update, real world experience in setting up an RI environment, and balancing the access and transparency of information for the regulated industry and consumer. Other topics for the month will include CFDI's new global drug inspection trend study, the use of technology in regulatory approvals, wearable devices and part two of the IDMP standards series on the global impact of the standards and implementation guidance.

Look for these feature articles and other hot topics throughout January.

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Categories: Biologics and biotechnology, Drugs, Medical Devices, Features


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