BioPharma

Oncobiologics: The most interesting biotech at #JPM17?

Oncobiologics has no home ground advantage. There is no clearly defined path with the FDA, EMA or any other regulatory agency. And it’s battling against the largest biotech and pharma companies in the world as they work to extend their patent exclusivity. How can it survive and bring biosimilars to the market at 50% of the cost?

Pills on scales biosimilars

Innovation. It’s why thousands of biotech, pharma and healthcare professionals are currently dashing around Union Square. It’s exciting and awe-inspiring and it captures the media’s attention.

At the other end of the spectrum is Oncobiologics, a company fully dedicated to producing biosimilars.

There’s no new pathway or technique involved in any of its work. Its mission is to replicate existing biologics. That means that everything depends on the efficiency and effectiveness of the business model. 

What can it deliver?

“We don’t believe that giving a 20-30 percent discount is going to move the needle in terms of healthcare savings,” said chairman, president and CEO Pankaj Mohan. “It needs to be more than that.”

On Monday afternoon, MedCity News sat down with Mohan to learn how to run a biotech with many unknowns, curve balls and zero room for waste.

Oncobiologics has no home ground advantage. There is no clearly defined path with the FDA, EMA or any other regulatory agency. And it’s battling against the largest biotech and pharma companies in the world, which have mobilized their resources to extend their patent exclusivity.

The path-to-market

The FDA and the EMA are ever-so-slowly getting there when it comes to biosimilar approvals, Mohan said. Both agencies are also willing and effective at working behind-the-scenes.

“For interchangeability, the guidance is not out yet from FDA,” he said. “But we have successfully been able to work and learn from FDA to create a program that they could approve.”

For its first asset, a biosimilar for Humira, Oncobiologics got the green light to combine the biosimilarity and interchangeability studies into a single Phase 3 trial.

“The regulatory path is becoming much, much clearer. I think the hurdle that I see is the IP landscape,” he said.

There’s a need for much greater political alignment in this area, Mohan said, to prevent the ‘evergreening’ of drug patents beyond their initial window of exclusivity.

That’s on the way.

2016 was a tipping point in the movement against high drug pricing and the overall cost of healthcare. This will continue, according to Mohan, irrespective of the election and any new political appointments.

“I would say it’s an irreversible socio-political movement.”

Production efficiency

Biosimilarity is established in the development phase, while the cost of goods depends on the manufacturing strategy. Many organizations establish their development and manufacturing operations in two different countries, Mohan explained. Others push the molecules through various contract research organizations.

With every transfer, inefficiency creeps in.

By combining the two components into a single, integrated facility, Oncobiologics can eliminate a lot of the waste associated with the tech transfer. Oncobiologcis does it all in-house, operating out of Cranbury, New Jersey.

It has also maximized the new single-use technology, which is replacing the old-fashioned stainless steel workflows. A single-use facility has a smaller footprint and the production cycle is much, much faster.

“From clone to IND is typically 18-24 months,” Mohan said of the company’s development timespan. “After that, the clinical program takes over.”

To maintain its efficiency right through to the patient, Oncobiologics is directly connecting with major healthcare networks, particularly in the U.S.

“Our focus in the U.S. is to network with end-users, selling our business model of best-in-class pricing and flexibility,” Mohan said. “For example, we have struck a partnership with Premier Healthcare, which is the largest hospital network in the U.S.”

With all of its cost-savings added up, how much of a discount on the brand name biologic can Oncobiologics hope to achieve?

“The way I would answer that is; to be able to really make an impact in the cost of drugs, somewhere around 50 percent is where it needs to be.”

Photo: Dmitrii Guzhanin, Getty Images

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