Epirus fixes on Europe for biosimilar base business
This article was originally published in Scrip
Boston-based biosimilar developer Epirus Biopharmaceuticals, which recently sewed up an alliance with China's Livzon Mabpharm, is keen to moor its business in Europe while pursuing growth in key emerging markets.
Epirus expects to initiate a Phase III trial in the EU for its Remicade (infliximab) biosimilar BOW015 in the first half of 2015 – the product is part of the Livzon alliance as well.
''We plan to build a profitable global biosimilar business anchored in Europe, while accessing growth in local production markets (such as China and Brazil) and opportunistically accessing emerging markets (such as India, Southeast Asia, and Latin America),'' Epirus CEO Amit Munshi told Scrip.
For markets like Europe, with an established biosimilar regulatory framework, Epirus expects to commercialize its products using a combination of direct sales and local distributors (scripintelligence.com , 21 July 2014).
Biosimilar Remicade is already available in certain EU markets through Alvogen under a strategic partnership with Hospira, which in turn has an agreement with Celltrion (scripintelligence.com, 13 February 2014). Celltrion's Remicade biosimilar has been approved by the European EMA, Japan PMDA, and Health Canada, among others, and the Korean firm recently filed for FDA approval (scripintelligence.com 11 August 2014).
On product supply plans for some regulated markets, now that Epirus has alliances in the ''pharmacies'' of the world – India and China – Mr Munshi said that for Europe supplies would be made ''direct from single use disposable systems at Fujifilm Diosynth Biotechnologies UK''. The Chinese firm will be the preferred supplier for ''Livzon markets'', while Reliance Life Sciences will essentially be responsible for India, other Ranbaxy territories, and likely Latin America, he added.
Fujifilm Diosynth is one of the leading contract manufacturing organizations for the biopharmaceutical industry. It was formed in 2011, following the acquisition of the former Diosynth Biotechnologies in the US and Avecia Biologics UK from Merck & Co.
While Epirus didn't share its specific view on the India versus China SWOT debate in the area of biologics manufacturing, Mr Munshi said that the Epirus Scale manufacturing platform would help partners in emerging markets quickly develop the requisite know-how and infrastructure to make biologic products to global standards.
''We have great confidence in our commercial and manufacturing partners in both markets," he declared
Epirus made its second recent advance in the Asian region with a broad-based deal for antibody-based drugs with Chinese biotech Livzon which owns roughly 12% of Epirus's outstanding common shares.
The Epirus-Livzon deal covers up to five biosimilar products including infliximab, with the partners expected to agree on additional products at a later date (scripintelligence.com 25 September 2014). Epirus's pipeline includes BOW050, a biosimilar version of Humira (adalimumab) and BOW030, its biosimilar Avastin (bevacizumab).
''Livzon and Epirus are currently developing a clinical and regulatory strategy in Livzon territories,'' Mr Munshi added. Livzon is expected to conduct any additional development work required for the approval of BOW015 in China and Taiwan – where it will also be the preferred supplier of the biosimilar.
In India, BOW015, the first infliximab biosimilar approved in the country, will be manufactured by Reliance Life Sciences at its site in Mumbai. Epirus had earlier entered into a licensing agreement with Ranbaxy for its biosimilar infliximab (scripintelligence.com 9 January 2014). Epirus/Ranbaxy anticipate a roll-out of the product by the first quarter of 2015.