United States: IGPA 2015 Focuses On Biosimilars, Quality, And Harmonization In Toronto-Part One Of Two

Last Updated: October 6 2015
Article by Brian J. Malkin

On September 16-18, 2015 the International Generic Pharmaceutical Alliance (IGPA) held its 18th Annual Meeting in Toronto, Canada. IGPA is composed of members: the Canadian Generic Pharmaceutical Association (CGPA-Canada), the European Generic and Biosimilars Medicines Association (EGA-Europe), the Generic Pharmaceutical Association (GPhA-USA), the Japan Generic Medicines Association (JGA-Japan), the Jordanian Association of Pharmaceutical Manufacturers (JAPM-Jordan), the National Association of Pharmaceutical Manufacturers (NAPM-South Africa), and the Taiwan Generic Pharmaceutical Association (TGPA-Taiwan) with the generic medicines associations of Australia, Brazil, and Mexico as Associate Members. Through its constituent member associations, the IGPA maintains constant dialogue with the International Conference on Harmonisation (ICH), the World Health Organization (WHO), the World Trade Organization (WTO), the World Intellectual Property Organization (WIPO), and other international organizations.

This year IGPA's Chair and President was Jim Keon, CGPA's Chair and President, who kicked off the main conference on September 17. Keon announced that in recognition of the increasing importance of biosimilars, IGPA will soon change its name to the International Generic and Biosimilars Association (IGBA). The Alliance recognizes that the success of generic and biosimilar markets depend on their reference innovator products and that specialty pharmaceuticals have increasingly become part of that picture.

Following a global dive into the generics market by Alan Sheppard, Principal, Global Generics, IMS Health, a Keynote Address followed by Eric Hoskins, Minister of Health and Long-Term Care, Province of Ontario. Hoskins thanked the generic pharmaceutical industry for helping to provide quality medicines to those in need and to help with the quality of life by bringing healthcare costs down. Hoskins said that he is working with the other Canadian provinces to increase use of generic medicines, recognizing that they work the same but cost less due to increased market competition. Hoskins explained that in Canada there is a tiered pricing for generic products based on competitor products and that there is an increasing need to work on drug substitution lists.

Key industry leaders from North America, Europe, and regional snapshots of ASEAN and the Middle East/North Africa, provided views of generic medicinal products expanding worldwide. In the U.S., approval times are starting to approve under the Generic Drug User Fee Act (GDUFA) but not as fast as predicted and with some slow downs based on an ever-increasing application load. In the European Union, sustainable pricing policies are needed, and there is good data to confirm that biosimilar products are as safe and effective as their referenced counterparts, suggesting additional opportunities for substitution. Hybrid products similar to 505(b)(2) NDAs in Europe are becoming more popular and further helping to fuel future growth. For ASEAN and Middle/East North Africa markets, there is increasing generic product development amidst some localized concerns of counterfeit products and recalls that affect all segments of the pharmaceutical industry periodically.

Howard Sklamberg, Deputy Commissioner for Global Regulatory Operations and Policy, FDA, discussed FDA's new Request for Quality Metrics Guidance issued some 50 days ago, and FDA's vision that quality metrics can predict disruptive mechanism and prevent the recalls or shortage situations. FDA is hoping that by monitoring drugs through their product life cycle from innovator to generic, FDA can identify areas of concern and document where quality exceeds regulatory requirements to provide not only sticks for poor performance but carrots for good work. The carrots may result in less frequent inspections and shorter review cycles for manufacturing changes, Sklamberg suggested. Sklamberg also said that FDA is looking for more objective ways to measure quality that is more obvious and fair rather than a laundry list of findings in an inspection report. In response to questions following the panel, he added that FDA is looking for input to its draft guidance and appreciates that the cost of inspections cannot be underestimated. Sklamberg added that FDA recognizes that companies may paradoxically find that by trying to avoid inspection reports they may actually cause more errors, which is why in part they are asking for industry input regarding the proposed quality metrics plan. In terms of mutual recognition of inspections by foreign authorities, Sklamberg said that at this point, FDA is not planning to add more countries to the current list, in part because FDA has found challenges with the process. FDA has found that while countries can share factual information about audits, the conclusions from those audits, e.g., whether regulatory action needs to be taken, rests within their respective legal systems rather than an objective result across the board.

Brendan Cuddy, Head of Manufacturing and Quality Compliance Service, European Medicines Association (EMA) said that the EMA is also concerned with supply disruptions, hoping to improve the supply side of products, e.g., sources of active pharmaceutical ingredients. Cuddy said that the EMA is looking at adverse events beyond Europe, because European medicines are consumed outside of Europe as well, and EMA continues to be concerned about data integrity. The EMA is looking for convergence to help support a more global approach to authorization and supervision of medicines. Yet there are issues of a lack of continuous improvement, reduced manufacturing by more company mergers, recalls and quality defects rising, less investment in products, and poor interactions between industry and the regulator making such convergence challenging. The EMA has witnessed known problems in product development that still make their way to production, leading to shortages later and failures in technology transfer. Cuddy asked, "Can you invest in quality when it seems unaffordable to compete?", referring in part to the lack of issue sharing between manufacturer and supplier, e.g., manufacturers rank suppliers internally but do not share the information with the supplier.

Ajaz Hussain, Founder & President, Insight, Advice and Solutions, LLC provided a provocative view of quality culture, suggesting that part of the issue is how predictably irrational humans are when it comes to pleasure and pain. Hussain described the "nocebo" effect, where the mere suggestion that a patient may experience negative symptoms in response to a medication (or a sugar pill) may be a self-fulfilling prophecy. This effect also makes patients think generic drugs as less good than their referenced counterpart, because they are perceived as copies of an original. Hussain sees quality by inspection as an ineffective way for companies to comply with regulatory requirements. In his experience, many companies attempt to create quality with an endless list of standard operating procedures (SOPs) that no one understands. While Hussain welcomes the concept of quality metrics, he does not believe industry is ready for FDA guidance yet. He does believe, however, that when mistakes are made, it is important to be transparent about them with regulatory authorities as a first step to rebuild trust along the road to fixing the underlying problem.

In the next panel, three lawyers provided perspectives on biosimilars patent litigation, patent linkage in Korea, and developments in antitrust competition law. Brian Malkin, Senior Counsel, McGuireWoods provided an overview of approval mechanisms, patent linkages, and patent challenge strategies for biosimilar products in Canada, the EU, Japan, and the United States. Malkin's presentation suggested that while each region may have different mechanisms to challenge patents, global product development models required understanding how to locate precedent from jurisdictions where key patents had been challenged. Seong-Ki Kim, Partner, Lee & Ko IP, provided an overview of Korea's patent linkage system, which indicated that while there has been some progress to develop patent linkage in Korea, more progress would be welcome to the generic industry. And William H. Rooney, Partner, Willkie, Farr and Gallagher LLP, explained the concept of "pay-for-delay" and "scope of the patent" in the context of antitrust litigations involving pharmaceutical products.

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