Pharmaceutical Technologist - July 2008 - (Page 14)

Generics cycles that are often required prior to final approval. Based on FDA statistics from all generic applications in 2001 and 2002, 93% of generic drug applications are not approved in the first cycle of review and 66% are not approved even after the second cycle of review.4 Delays in approval can be costly for generic companies that are usually aiming to meet patent expiry timelines in competition with other players. This is particularly important in the US as the first generics company to successfully file a challenge to a big pharma drug patent can gain a 180-day market exclusivity period. Figure 1 illustrates the lengthy, albeit declining, ANDA approval time.3 The state of Europe The situation in Europe could be considered even more onerous as the authorization procedure has traditionally been less harmonized than the US. The European Medicines Agency (EMEA) enables pharmaceutical companies to have their products licensed for sale in all EU countries through the Mutual Recognition Procedure. In this instance, the company submits a request for marketing authorization to one of the member states. The decision is then considered, adopted and recognized by the concerned member states. The complexity in Europe arises from the fact that, historically, individual countries have worked to their own national provisions, which often means that what may be acceptable in one member state is not allowed in another. Legislation aimed at reducing this complexity came into effect in November 2005 and created a harmonized EU 8-year data exclusivity provision, with an additional 2-year market exclusivity extendible by 1 year for new indications.6 This means marketing authorizations can be submitted by generics companies after 8 years, but products may not marketed until after 10–11 years. This is harmonized throughout the EU, as shown in Figure 2. Refining processes To overcome these hurdles and facilitate progress through the prevailing regulatory procedures, generics companies from the emerging market have developed and refined their operational processes. This includes, in some instances, acquiring companies and establishing approved manufacturing sites in regulated territories, as listed in Table 1. Ensuring adequate product development is performed prior to submitting applications, providing prompt feedback and addressing any additional information requirements from regulators is central to an efficient regulatory procedure. Early communication with regulators is critical as companies seek to identify and resolve any issues in the regulatory process as soon as they arise. Figure 1 Median ANDA approval times reported by the OGD. 20 18 16 14 Months 12 10 8 6 4 2 0 Intellectual property Pharmaceutical companies also face intellectual property barriers in regulated markets. Big Pharma implements life cycle management strategies, underpinned by strengthening, extending and defending patent estates. It often builds layers of protection by obtaining separate patents on multiple attributes of a single product, which is a strategy known as ‘evergreening’.6 The filing of additional patents makes it more difficult for a generics company to make a case for noninfringement or invalidity when for marketing authorization. In addition, many big pharma companies extend their patent protection by applying for patent term restoration (applicable in the US) and supplementary protection (applicable in Europe). This tactic is an attempt to extend patent protection beyond the 2000 2001 2002 2003 Fiscal year 2004 2005 2006 Figure 2 How data exclusivity affects the application of a generic medicine in the EU. Data exclusivity Market exclusivity 8 years 2 years (1 year) Marketing authorization of reference product Generics application Generics launch no new patent 8+2(+1) Data exclusivity formula 14 JULY 2008 PHARMACEUTICAL TECHNOLOGIST

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Pharmaceutical Technologist - July 2008 Contents Industry Highlights Morpheus Market Watch Overcoming the Barriers The Tide of Change Eight Steps to Improved Water Efficiency Q&A

Pharmaceutical Technologist - July 2008

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