Generic pregabalin: current situation and implications for health authorities, generics and biosimilars manufacturers in the future

  title={Generic pregabalin: current situation and implications for health authorities, generics and biosimilars manufacturers in the future},
  author={Brian B Godman and Michael Wilcock and Andrew Martin and Scott M Bryson and Christoph Baumg{\"a}rtel and Tomasz Bochenek and Winne de Bruyn and Ljiljana Sovi{\'c}-Brki{\vc}i{\'c} and Marco D’Agata and Antra Fogele and Anna Coma Fust{\'e} and Jessica Fraeyman and Jurij F{\"u}rst and Kristina Garuolienė and Harald Herholz and Mikael Hoffmann and Sisira Jayathissa and Hye-Young Kwon and Irene Langner and Marija Kalaba and Eva Anders{\'e}n Karlsson and Ott Laius and Vanda Markovi{\'c}-Pekovi{\'c} and Einar Magn{\'u}sson and Stuart McTaggart and Scott Metcalfe and Hanne Bak Pedersen and Jutta Piessnegger and Anne Marthe Ringerud and Gisbert W. Selke and Catherine Sermet and Krijn M. H. Schiffers and Peter Skiold and Juraj Slab{\'y} and Dominik Tomek and Anita Viksna and Agnes Vitry and Corinne Zara and Rickard E. Malmstr{\"o}m},
  journal={Generics and Biosimilars Initiative journal},
The manufacturer of pregabalin has a second use patent covering prescribing for neuropathic pain: its principal indication. The manufacturer has threatened legal action in the UK if generic pregabalin rather than Lyrica is prescribed for this indication. No problems exist for practitioners who prescribe pregabalin for epilepsy or generalized anxiety disorder. This has serious implications for health authorities. In Germany, however, generics could be legally prescribed for any approved… 

Pricing of oral generic cancer medicines in 25 European countries; findings and implications

The considerable price reductions seen for some generics means health authorities should further encourage the use of generic oncology medicines when they become available to fund increased volumes and new valued cancer medicines.

Assessment of active pharmaceutical ingredients in drug registration procedures in Pakistan : implications for the future

There is an urgent need to improve the registration process for generic products in Pakistan, including implementing Common Technical Documents based on international standards, and to see generics being produced that result in improved patient care and that have potential for export from Pakistan.

Mapping of Current Obstacles for Rationalizing Use of Medicines (CORUM) in Europe: Current Situation and Potential Solutions

There is an urgent need to improve RUM through improved educational and other activities among European countries, with countries learning from each other.

Utilisation Trend of Long-Acting Insulin Analogues including Biosimilars across Europe: Findings and Implications

Enhancing the attractiveness of the biosimilar insulin market is essential to encourage other biosimilar manufacturers to enter the market as more long-acting insulin analogues lose their patents to benefit all key stakeholder groups.

Barriers for Access to New Medicines: Searching for the Balance Between Rising Costs and Limited Budgets

The primary aim of this paper is to consider potential ways to optimize the use of new medicines balancing rising costs with increasing budgetary pressures to stimulate debate especially from a payer perspective.

Rapid Assessment of the Potential Paucity and Price Increases for Suggested Medicines and Protection Equipment for COVID-19 Across Developing Countries With a Particular Focus on Africa and the Implications

Concerns with increased utilisation of antimicrobials needs addressing alongside misinformation, unintended consequences from the pandemic and any appreciable price rises.

One-day out-patient prescribing patterns at a national referral hospital in Kenya

There is a need to increase the rate of prescribing of generics to save costs as well as reduce stock-out levels by instigating a comprehensive generics policy.

Barriers and facilitators of exploiting the potential of value-added medicines

Current practices may need to be reconsidered to exploit the full societal benefit of VAMs, including more efficient policies to guarantee market exclusivity for incremental innovation, acknowledgment of a fair price premium based on a specific value framework and the acceptance of low-cost evidence generation methods.

Economic and social cost of epilepsy in Poland: 5-year analysis

The most current direct and indirect costs of epilepsy in Poland from the social perspective for the years 2014-2018 are determined to analyze the changes of expenditures over time, indicate trends and to determine key cost-drivers.

Bioequivalence, Drugs with Narrow Therapeutic Index and the Phenomenon of Biocreep: A Critical Analysis of the System for Generic Substitution

In Italy, the regulatory authority has established the Transparency Lists which include the medications that will be automatically substituted for brand-name drugs, except in exceptional cases, which is a useful tool to guide prescribers and guarantee pharmaceutical sustainability, but it does not consider the biocreep phenomenon.



What lessons can be learned from the launch of generic clopidogrel

There was appreciable variation in the initial price reductions for generic clopidogrel versus the originator, and authorities can take full advantage of the early availability of generics despite different formulations and indications.

Generic olanzapine: health authority opportunity or nightmare?

A retrospective survey of patients prescribed Zyprexa®, generic olanzapine or both, over an extensive period was undertaken in Poland to help address patient and physician concerns given the difficulties with conducting randomized clinical trials with generics in complex situations.

Generic and therapeutic substitutions in the UK: are they a good thing?

The tension that exists between the clinical appropriateness and safety of switching from an individual patient perspective and the consideration of value for money which is required to maximize population health from a health service perspective is explored.

European countries with small populations can obtain low prices for drugs: Lithuania as a case history

The findings demonstrate that it is possible for European countries with smaller populations to engineer low prices with manufacturers, as seen in Lithuania among classes with currently limited utilization versus Western European countries, as well as those with similar utilization patterns.

Margaret McCartney: Second use patents—why do we have to prescribe branded Lyrica for pain?

  • M. McCartney
  • Medicine, Political Science
    BMJ : British Medical Journal
  • 2015
Pfizer wrote to pharmacists this year to tell them that generic prescribing of pregabalin for pain would be “unlawful” and would be contrary to government policy “of rewarding additional research by the granting of a second use patent".

Imperative to consider multiple initiatives to maximize prescribing efficiency from generic availability: case history from Abu Dhabi

PPI utilization rose by 6.5-fold from 2004 to 2010, principally driven by increased utilization of patent-protected PPIs, although more recently stabilization in esomperazole utilization has occurred.

Seizure Outcomes Following the Use of Generic versus Brand-Name Antiepileptic Drugs

The available evidence does not suggest an association between loss of seizure control and generic substitution of at least three types of AEDs, and physicians may want to consider more intensive monitoring of high-risk patients taking Aeds when any switch occurs.

Pfizer loses UK patent for blockbuster pain drug after threats to doctors

  • Z. Kmietowicz
  • Political Science, Medicine
    BMJ : British Medical Journal
  • 2015
The drug company Pfizer made unjustifiable threats when it said earlier this year that prescribing generic versions of pregabalin, which it markets as Lyrica, for pain control could leave doctors

Generic clozapine: outcomes after switching formulations

  • C. Paton
  • Psychology, Medicine
    British Journal of Psychiatry
  • 2006
Clinical outcomes for all patients switched from Clozaril® to a generic formulation in one mental health service were determined and there was no evidence of clinical deterioration or need to use higher dosages.

Generic Medicines: Solutions for a Sustainable Drug Market?

Governments must focus on demand-side policies, alongside policies to accelerate market access, as the generic medicines industry will only be able to deliver competitive and sustainable prices if they are ensured a high volume.