Indication-Specific Generic Uptake of Imatinib Demonstrates the Impact of Skinny Labeling

PURPOSE Generic competition can be delayed if brand-name manufacturers obtain additional patents on supplemental uses. The US Food and Drug Administration allows generic drug manufacturers to market versions with skinny labels that exclude patent-protected indications. This study assessed whether use of generic versions of imatinib varied between indications included and excluded from the skinny labels. METHODS In this cross-sectional study, we identified adult patients covered by commercial insurance or Medicare Advantage plans who initiated imatinib from February 2016 (first generic availability) to September 2020. Generic versions were introduced with skinny labels that included indications covering treatment of chronic myelogenous leukemia (CML) but excluded treatment of gastrointestinal stromal tumors (GISTs) because of remaining patent protections. Logistic regression was used to determine whether use of generic versus brand-name imatinib differed between patients with a diagnosis of CML or GIST, adjusting for demographics, insurance type, prior use of brand-name drugs, and calendar month. RESULTS Among 2,000 initiators, 934 (47%) had CML and 686 (34%) had GIST. Within 3 years after generics entered the market, more than 90% of initiators in both groups used generic imatinib. Initiation of generic imatinib was slightly lower among patients with GIST than among patients with CML (85% v 88%; adjusted odds ratio 0.56; 95% CI, 0.39 to 0.80; P ≤ .001). CONCLUSION Generic versions of imatinib were dispensed frequently for indications both included (CML) and excluded (GIST) from the skinny labeling, although patients with GIST were slightly less likely to receive a generic version. The skinny labeling pathway allowed generics to enter the market before patent protection for treating patients with GIST expired, facilitating lower drug prices.

The Rise of the State: Broadband Policy in New Zealand 2000-2011

<p>Between 2000 and 2011, changes in government policy significantly increased the role of the state in telecommunications markets in New Zealand. In both regulatory and investment activities, the historic approach of liberal market regulation was transformed into active intervention. This changed approach aimed at speeding access to high-speed broadband services. There was a remarkable lack of political debate between the major political parties as to the objective being sought, or direction of policy towards greater intervention in order to achieve it. This research outlines in broad terms the background to the debates underpinning policy change, and the history of New Zealand’s approach. It outlines in detail the key policy changes made. In the regulatory domain, four key changes are discussed. These are: the implementation of sector-specific legislation (Telecommunications Act 2001); the decision not to unbundle the copper local loop (2004); amendments to the Telecommunications Act strengthening the regulator and imposing ‘operational separation’ of Telecom (2006); and the ‘structural separation’ of Telecom and the debate on regulatory forbearance (2011). By the end of the case period, these changes meant that generic competition law had been replaced by sector-specific legislation, a specialist regulator with broad powers to monitor and regulate the industry, and a leading solution to discrimination issues with the complete ownership separation of network and services in copper and fibre-optic telecommunications networks. In the investment domain, five key stages are discussed. These are: Project PROBE (2001-4), the Broadband Challenge (2005), the Broadband Investment Fund (2008), the Ultra-Fast Broadband Initiative (2009) and the Rural Broadband Initiative (2009). Together these saw public spending on telecommunications infrastructure rise from nothing in 2000, to a combined package in the two final (and current) initiatives of around $1.6bn of public funds. This money combines with private investment to deliver fibre-optic broadband infrastructure to three-quarters of homes, and significant improvements to the availability of higher-speed broadband in rural and remote parts of New Zealand. Increasing levels of government intervention in these markets was an opportunity for considerable political contest. Instead the case period 2000-2011 is characterised by similarities rather than differences between National and Labour. The thesis suggests that an explanation for this similarity arose from the perceived importance of high-speed broadband infrastructure for New Zealand’s economic prospects, and a shared analysis by Labour and National that market provision would not suffice. This imperative defeated temptations to politicise the project.</p>

The Rise of the State: Broadband Policy in New Zealand 2000-2011

<p>Between 2000 and 2011, changes in government policy significantly increased the role of the state in telecommunications markets in New Zealand. In both regulatory and investment activities, the historic approach of liberal market regulation was transformed into active intervention. This changed approach aimed at speeding access to high-speed broadband services. There was a remarkable lack of political debate between the major political parties as to the objective being sought, or direction of policy towards greater intervention in order to achieve it. This research outlines in broad terms the background to the debates underpinning policy change, and the history of New Zealand’s approach. It outlines in detail the key policy changes made. In the regulatory domain, four key changes are discussed. These are: the implementation of sector-specific legislation (Telecommunications Act 2001); the decision not to unbundle the copper local loop (2004); amendments to the Telecommunications Act strengthening the regulator and imposing ‘operational separation’ of Telecom (2006); and the ‘structural separation’ of Telecom and the debate on regulatory forbearance (2011). By the end of the case period, these changes meant that generic competition law had been replaced by sector-specific legislation, a specialist regulator with broad powers to monitor and regulate the industry, and a leading solution to discrimination issues with the complete ownership separation of network and services in copper and fibre-optic telecommunications networks. In the investment domain, five key stages are discussed. These are: Project PROBE (2001-4), the Broadband Challenge (2005), the Broadband Investment Fund (2008), the Ultra-Fast Broadband Initiative (2009) and the Rural Broadband Initiative (2009). Together these saw public spending on telecommunications infrastructure rise from nothing in 2000, to a combined package in the two final (and current) initiatives of around $1.6bn of public funds. This money combines with private investment to deliver fibre-optic broadband infrastructure to three-quarters of homes, and significant improvements to the availability of higher-speed broadband in rural and remote parts of New Zealand. Increasing levels of government intervention in these markets was an opportunity for considerable political contest. Instead the case period 2000-2011 is characterised by similarities rather than differences between National and Labour. The thesis suggests that an explanation for this similarity arose from the perceived importance of high-speed broadband infrastructure for New Zealand’s economic prospects, and a shared analysis by Labour and National that market provision would not suffice. This imperative defeated temptations to politicise the project.</p>

Regulatory aspects for competitive Generic Therapies in USA

The FDA Reauthorization Act (FDARA) of 2017 lets generic companies ask for expedited review and 180-day exclusivity for a Competitive Generic Therapies (CGT)-designated product. (1) FDA guidance for industry on Competitive Generic Therapies (CGT) provides keen information for generic drug manufacturers who want to develop a drug with inadequate generic competition. This guideline is specially published for generic players. If you are a generic manufacturer or sponsor, this will Explain the process and criteria to request and designate a drug as a CGT. Information on the actions FDA may take to expedite the development and review of ANDAs designated as CGT. Implementation of 180-day exclusivity period for certain first approved applicants that submit ANDAs for CGTs. (1)

Market Exclusivity of the Originator Drugs in South Korea: A Retrospective Cohort Study

Introduction: Generic entry is a well-known driver of competition and cost containment.Objectives: We aim to measure the market exclusivity of originator drugs and to determine what influences the entry of generics in South Korea.Methods: A list of originator drugs approved by the authority from 2000 to 2013 and their corresponding generics were paired. An event history model was applied for a statistical estimation for the duration until generic entry and to identify abbreviating or prolonging factors on the duration.Results: A total of 2,061 pairs of originator and generics were identified. The market exclusivity for the originator drugs, including NDAs and non-NDAs, has not notably changed. However, competition among non-NDAs was less common than we expected. We found delayed time to entry of generics in the long run, particularly for non-NDAs in injection forms and biologics, and this finding is partially associated with market attractiveness.Conclusion: The authority should address the delayed availability of certain types of generic drugs. The government could provide information on off-patent pharmaceuticals with no generic competition, designate their corresponding submissions as prioritized in the review process, and provide additional market exclusivity when entering the market via a long period of exclusivity.

Does NICE influence the adoption and uptake of generics in the UK?

The aim of this paper is to examine generic competition in the UK, with a special focus on the role of Health Technology Assessment (HTA) on generic market entry and diffusion. In the UK, where no direct price regulation on pharmaceuticals exists, HTA has a leading role for recommending the use of medicines providing a non-regulatory aspect that may influence the dynamics in the generic market. The paper focuses on the role of Technology Appraisals issued by the National Institute for Health and Care Excellence (NICE). We follow a two-step approach. First, we examine the probability of generic entry. Second, conditional on generic entry, we examine the determinants of generic market share. We use data from IQVIA British Pharmaceutical Index (BPI) for the primary care market for 60 products that lost patent between 2003 and 2012. Our results suggest that market size remains one of the main drivers of generic entry. After controlling for market size, intermolecular substitution and difficulty of manufacturing increase the likelihood of generic entry. After generic entry, our estimates suggest that generic market share is highly state dependent. Our findings also suggest that while NICE recommendations do influence generic uptake, there is only marginal evidence they affect generic entry.

Is greater generic competition also linked to lower drug prices in South Korea?

Background Although the association between the price of generic drugs and market competitiveness has been explored in various high-income countries, this association has not been empirically evaluated in South Korea. We aim to determine the association between the prices of generic drugs and market competitiveness in South Korea. Methods A list of originator drugs approved by the national authority from 2000 to 2019 and their corresponding generic drugs were grouped along with the baseline information. The market was categorized into four groups based on the number of manufacturers: duopoly (2 manufacturers); low- (3–25 manufacturers); medium- (26–75 manufacturers); and high-competition (more than 76 manufacturers) markets. Price variance, calculated as the difference between the maximum price and minimum price divided by the maximum price, was obtained. A multivariate regression model was applied to regress price variance on the characteristics of market competitiveness, controlling for the characteristics of the originator drugs and their price level in the market. Results A total of 986 originator drugs were identified and then divided into duopoly (31%), low- (56%), medium- (9%), and high-competition (4%) markets; the median of the price variance for these markets was 0.013, 0.077, 0.200, and 0.228, respectively. In a multivariate regression model, price variance was associated with the characteristics of the originator drug, including the Anatomical Therapeutic Chemical classification, the route of administration, and the approval year. Controlling for the characteristics of the originator drugs, market competitiveness was positively associated with price variance. Conclusions The positive association between price variance and market competitiveness is still consistent in South Korea, where rare price competition among a large number of generic manufacturers has been reported. However, no significant price variance was observed between medium- and high-competition markets. These findings support policies for managing a large number of generic manufacturers in South Korea.