The broad pact between the companies will see inVentiv running and offering bioanalytical support for the clinical trials of biosimilar versions of Humira, Rituxan, Avastin, Herceptin and Erbitux in Oncobiologics’ pipeline. These biologics are currently bringing in more than $40B in annual revenue for AbbVie, Genentech and Bristol-Myers Squibb. None of the biosimilars have entered Phase I trials yet, according to the Oncobiologics pipeline.
inVentiv will also offer commercialization capabilities in select but yet to be identified countries once the biosimilars reach the market.
Raymond Hill, president of inVentiv Health Clinical, told Outsourcing-Pharma.com that the deal came together because of inVentiv’s ability to provide the typical CRO clinical services and to offer a flexible, risk-sharing approach that allows Oncobiologics to defer some of its start-up costs in exchange for the future commercialization of the biosimilars.
He said this particular deal, which doesn’t have a specific timeframe but may last for around five years, works for Oncobiologics because inVentiv is developing a whole pipeline of biosimilar and biotherapeutic products that can benefit from inVentiv’s clinical capabilities on the front end, and help Oncobiologics “on the back end” with inVentiv’s multi-million dollar public relations and advertising business.
By deferring some of its upfront capital, the deal allows Oncobiologics investors to not worry about lost resources “until their pipeline is more proven,” Hill said, noting the partnership could expand to include other molecules.
Hill also noted that this risk-sharing deal is new for the company and its private equity owner Thomas H. Lee and Partners but it will be part of a future trend for the company as smaller biotech companies that cannot afford to lose early capital seek out such deals.
Manufacturing Partnership
The inVentiv partnership follows a similar announcement from February when Oncobiologics selected Viropro to manufacture the biosimilars. Viropro will have exclusive commercialization rights to the biosimilars for Malaysia and the companies will co-manage Viropro’s Penang, Malaysia Alpha Biologics biomanufacturing subsidiary.
The companies projected that Viropro’s commercial and manufacturing royalties have the potential to grow to an annual revenue run rate of $60–$150 million for Viropro within 10 years. The partnership is planning to launch its first product by late 2014.
Trends in Biosimilar Development
The task of bringing biosimilars to market, however, has proven difficult for most of the companies looking to capitalize on what some see as a hot new market.
Lonza and Teva recently announced that they would abandon their biosimilar joint venture because of the costs and time necessary to bring the products to market.
Hill acknowledged those issues as well as those of Merck and Samsung in bringing biosimilars to market, especially since the US FDA has yet to establish a pathway by which to approve the follow-on biologics.
But he still remains positive, adding, “From a cost basis there’s a strong argument that [Oncobiologics] have a good shot at bringing biosimilars to market and we wouldn’t have signed with them if we thought otherwise.”