Insulin blockbusters targeted by biosimilar blitz
pharmafile | February 15, 2013 | News story | Research and Development, Sales and Marketing | Biocon, Humalog, Mylan, insulin
Mylan and Biocon are the latest companies to announce major new plans to develop and market biosimilars.
The firms are to combine forces to develop and market biosimilar versions of three top-selling insulin products.
Both are major players in the generics field, but developing, gaining approval and marketing biosimilars is far more complex and resource-intensive than traditional generics.
The new deal gives Mylan rights to develop and market Biocon’s version of Sanofi’s Lantus, called Glargine, Lispro (its version of Lilly’s Humalog) and Aspart (a copy of Novo Nordisk’s NovoLog).
The company still has a long way to go in developing and marketing the products, however. Last July it announced that a Phase I comparative PK-PD study showed its product was bioequivalent to Lantus, but it must now conduct a Phase III trial to provide sufficient data for regulators.
It is these substantial development costs (plus capital and certain other costs) which the firms will share to bring the products to market. Mylan will have exclusive rights to market the products in the US, Canada, the European Union and the European Free Trade Association countries; and Australia, New Zealand.
Biocon will benefit from a profit-share arrangement based on sales from these leading regions, meanwhile in other regions the firms will share marketing rights.
Worldwide sales of Lantus, Humalog and NovoLog were approximately $11.5 billion in 2012, with Sanofi’s blockbuster Lantus accounting for more than half of this total.
Traditional generics usually decimate sales of blockbuster products they copy, but biosimilars are not expected to seize as great a market share from the originals. There are a number of reasons for this, not least that biosimilar firms can’t offer huge discounts to the originals, as they must recoup their own high development costs.
But Mylan and Biocon hope that by sharing these costs they can undercut the established insulin firms and seize a lucrative slice of the global market.
Mylan’s chief executive Heather Bresch, said: “This collaboration builds on our existing successful partnership for generic biologics with Biocon and brings Mylan a portfolio of high-value insulin analogue products. This collaboration further expands and diversifies our pipeline of complex, difficult-to-manufacture products with strong future growth potential.
“Importantly, we believe we have the opportunity to be one of the first generic entrants in developed markets into the rapidly growing diabetes area, helping to address unmet needs and reduce the economic burden to those battling the disease and to the global healthcare system.”
The firms first established a drug development partnership three years ago, and have expressed confidence in building on their existing relationship.
Mylan president Rajiv Malik said: “Our thorough review of the development work completed by Biocon to date on these products gives us great confidence in the company’s capabilities in this area and in the quality and value of this programme.
“Our confidence in the potential of this programme is supported by our proven ability to drive value from our partnership with Biocon and we believe Mylan is uniquely positioned to work with Biocon to bring these products to market.”
Biocon is India’s largest biotech company by revenue. Like many other Indian generics firms, its core business is in generics and manufacturing and clinical services, but is expanding into its own proprietary research.
Biocon’s chairman and managing director, Kiran Mazumdar-Shaw said: “Mylan is a natural preferred partner for our portfolio of generic insulin analogues and this collaboration only further strengthens our existing successful partnership.
“We are confident that together we can build a strong global presence in generic insulin analogues and provide access to affordable therapy options to physicians, healthcare providers and diabetes patients worldwide.”
The race for rituximab
Recent news has illustrated the difficulty in developing biosimilars – in October Samsung announced that it was halting its development of its version of blockbuster cancer and rheumatoid arthritis treatment rituximab (Roche and Biogen’s Rituxan/Mabthera).
The reason for the hiatus remains unclear, but may be to do with uncertainty about regulatory pathways and approval. Samsung is understood to be in discussion with the FDA officials about clinical development requirements.
Generics giant Teva also suspended its late-stage development of a Rituxan biosimilar just a week before Samsung. Teva is understood to be weighing its options regarding filing the drug – rituximab loses its patent in Europe in November this year, while the US patent will be in place until 2018.
Meanwhile Sandoz (Novartis’ generics division) and Celltrion are believed to be in pole position to launch the first biosimilar of the drug, with Phase III results for oncology expected this year, with an approval forecast for 2014.
Andrew McConaghie
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