Sydney. NSW (PRWEB) April 09, 2013
The article by GenericsWeb highlights the following observations in relation to generic Insulin Glargine:
- The most significant constraint to the launch of a biosimilar Insulin Glargine comes from patent families protecting the active ingredient per se.
- Family DK113585A (12/03/1985) claims Insulin Glargine generally. European patent EP0254516 was extended by supplementary protection certificates (SPC) in France and Germany until July 2012 and EP0280534 was extended in Spain and the UK until February 2013. Due to expiry of all patent and SPC terms, this patent family essentially offers no further protection of the Lantus product.
- However, patents having specific product claims for the Insulin Glargine molecule are considered to further constrain generic launch.
- Sanofi Aventis has complied with an agreed paediatric investigation plan (PIP) and subsequently applied for paediatric extensions which, if granted, will extend the SPC by a further 6 months to May 2015.
- The patent term in the US will run until February 2015.
- Insulin pen delivery devices and are owned by companies other than Sanofi Aventis, but a variety of third parties have developed their own disposable pen devices and would enjoy the opportunity to use their technology for biosimilar products, so a direct competitor to SoloStar is not unlikely.
- The US patent in the family to protect the market authorised formulation has been extended 6 months via paediatric extension. Significant development efforts go into the formulation of biologics, but it is likely that this patent will be circumvented by generic reformulation.
- It is likely that the process patent would be circumvented by any potential generic entrant.
- At this stage, there have been no generic marketing authorisations in any of the major markets even though data exclusivity has expired.
- However, biosimilar Insulin Glargine is available in emerging markets where patent protection has expired or is absent, such as India.
- No generic competitors appear in the top 5 patentees, the space being taken by the three most likely innovator companies.
- The continual post approval filing around processes and formulations from innovator companies relate to their development of better methods of producing, purifying and formulating insulin and underscores the complexity of the IP Landscape that any generic entrant will need to understand and navigate.
- The amount of formulation patents, around 30% of the applications protect technologies relating to less invasive routes of administration such as oral and nasal insulin formulations, showing an area of future development in the delivery of insulin.
GenericsWeb notes that: “the evidence suggests that Sanofi Aventis will lose a significant portion of its revenue derived from Lantus in early 2015 to generic competition. How much of the market will switch to biosimilar Insulin Glargine once it becomes available will depend highly on the price (which in turn is dependent on the number of market entrants), the device technology differences and, perhaps most importantly, trust in the safety and efficacy a biosimilar medicine which is to be taken by a patient on a daily basis for an indefinite period. One further consideration is how the market for Lantus will change given the impending launch of Novo Nordisk’s Tresiba® will this spoil the generic market leaving a few holes in the balance sheets of some major generics companies, or will the availability of biosimilar Insulin Glargine have the same effect on new Tresiba sales – the race is on.”
You can read the entire article here at: http://www.genericsweb.com/druginfocus/Insulin_Glargine
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