While Teva Pharmaceutical Industries is the world’s largest generic drugmaker with 2013 net sales close to $10bn (€8.6bn), the firm is also a self-proclaimed pioneer in biosimilar development having invested in R&D and manufacturing of such copycat biologics since 2000.
But at last week’s JP Morgan Healthcare Conference in San Francisco, CEO Erez Vigodman told stakeholders Teva’s strategy “goes beyond biosimilars,” citing its proprietary monoclonal antibody (mAb) Reslizumab – an interleukin-5 (IL-5) candidate being investigated to treat asthma exacerbations - recently showed positive Phase III trial results.
“We are asked a lot about biosimilars but basically the question is about biologics,” he said. “We see the prominent role of biologics in the industry in a way that gains more and more momentum.”
He added, however, that for Teva to produce biologics like reslizumab and LBR-101 – a Phase IIb anti-CGRP mAb acquired when Teva bought Labrys last June for $200m – the firm would need to expand its manufacturing network.
“We need basically biologic capabilities and development capabilities,” he told investors. “Teva is committed to develop the infrastructure which is required in order to basically tap the opportunities that will emanate from the biologic universe, it is critical in the industry.”
Teva has expanded its biologics network through acquisitions. The firm bought Sicor Biotech in 2004 which included a microbial site in Lithuania and plants in Mexico, China and Latvia that develop and manufacture biosimilar materials such as interferon alpha and human growth hormone.
In 2010, Ratiopharm was acquired and a mammalian cell culture manufacturing plant in Ulm, Germany was added and now produces versions of Amgen’s Neupogen and Epogen.
The company has also relied on third party biomanufacturers, signing a joint venture with Lonza in 2009 for the development, manufacturing and marketing of biosimilars, carried out at Lonza’s commercial scale mAb manufacturing facilities. However, this collaboration ended in 2013.
The need to grow its manufacturing network lies contrary with Teva’s efficiency drive which could see it halve the 75 production sites over the coming years in a bid to save up to $2bn annually.
Despite an interest in proprietary biologics, Vigodman said the firm was still focused on biosimilars and will use new infrastructure to “compete in a very successful manner in the biosimilar space.”
This was conformed to Biopharma-Reporter.com by Teva spokesperson Denise Bradley. “We are committed to strengthening our biosimilars portfolio, both on our own as well as through a possible partnership.”
She continued: “We are strong in Wave 1 biosimilars – those with no remaining patent protection – with revenues of roughly $400M. We maintain a limited program in Wave 2 biosimilars, or those products that will see patents expire between 2015 and 2020.
“Additionally, we have very early programs in Wave 3 biosimilars, or those that have patent protection beyond 2020.”