From The Editor | September 21, 2016

How To Prepare Your Biosimilar Company For Interchangeability

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By Anna Rose Welch, Editorial & Community Director, Advancing RNA

How To Prepare Your Biosimilar Company For Interchangeability

At the inaugural GPhA Biosimilars Council’s Leading on Biosimilars conference, I was made privy to the industry’s many opinions and questions about interchangeability. While biosimilar makers are anxiously awaiting interchangeability guidance from the FDA, there did not seem to be a united or clear opinion about whether interchangeability will be a beneficial strategy for biosimilar makers. However, in an interview, Pankaj Mohan, CEO of pure-play biosimilar company Oncobiologics, offered a very straight-forward and optimistic perspective. “Interchangeability will be a game changer for biosimilars,” he said.

So far in the biosimilar space, we’ve witnessed several regulatory triumphs from large, well-known brand companies, including Amgen, Pfizer, Sandoz/Novartis, and Biogen. As it’s still a nascent industry, many of the larger companies are in a stronger position financially and in terms of capacity to get their biosimilar products to market faster. But Mohan expects that when it comes to interchangeability, smaller companies could have an advantage over biosimilars from big, recognizable brands.

Interchangeability Success Relies On More Than Just Branding

Oncobiologics is currently at work on a pipeline of four monoclonal antibody biosimilars for Humira, Avastin, Herceptin, and Prolia. Farthest along in development is its Humira biosimilar (ONS-3010), which began receiving EU clinical trial authorization (CTA) approvals for its planned global Phase 3 trials in June 2016. Following discussions with the European Medicines Agency (EMA) and the FDA, this protocol also includes testing intended to enable interchangeability in the U.S.

Oncobiologics approached the FDA last year to discuss interchangeability for its Humira biosimilar and to learn the FDA’s expectations for this designation. “Following review of the FDA’s draft guidance, we developed a protocol, which we took back to the FDA and earned its blessing,” Mohan said.

For competitive reasons, Mohan could not discuss some of the specific challenges the company faced creating this protocol. However, he did share there were a few surprises in the FDA’s guidelines. “When I first reviewed the guidelines, I was surprised to see certain specifications for part of the design,” Mohan offered. “They are different compared to what’s being done in Phase 3 trials today. But I certainly see the FDA’s reasoning behind these specifications.”

When determining whether to choose the interchangeability development path, Mohan considered the company’s business model. Despite being a small (but still growing) company, employing around 100 employees, Oncobiologics has its own in-house development and manufacturing capabilities. This enables the company to accelerate development and carry out tech transfers much more quickly than larger companies or those that outsource their development and manufacturing. Unlike a larger company, which might house departments in different buildings, Oncobiologics’ departments are housed together, enabling close interaction and more efficient, collaborative decision making. Mohan described, “By embedding large pharma capabilities in a small biotech culture, we are able to move faster while keeping costs low.” For instance, it takes Oncobiologics roughly six weeks to do a tech transfer compared to six to 18 months in large companies or for those using contract manufacturing organizations (CMOs).

This business structure promotes what Mohan referred to as “pricing flexibility.” It’s a truth universally acknowledged in the pharma industry that more efficient development leads to lower costs. This is then reflected in the price a company ultimately charges for its medicines. Mohan argued building in-house development capabilities provides the company with a competitive discount structure for its biosimilars. And when interchangeability is introduced in the U.S., price will be a major deciding factor for which biosimilar is recommended by payers and doled out by pharmacists.

According to Mohan, “While branding is important, it may not be the most important factor for interchangeability because the switch at the pharmacy level is driven by the insurance company, the state, and the pharmacy. This means the biosimilar being distributed will likely be the one offering the best discount.” Therefore, interchangeability creates the perfect opportunity for a smaller company with lower development costs to effectively compete against larger brand companies and secure a greater potential chunk of the biosimilar market.

The Role Of The Brand In Interchangeability

Even though pricing will play a larger role in interchangeability, branding is still important when biosimilar makers compete against companies like Amgen and Pfizer.

As Mohan described, “One needs to brand in terms of their scientific rigor.” For Oncobiologics, scientific rigor means emphasizing it employs scientists with experience working in Big Biotech. In addition, because of the great need for patient and physician education on the science behind biologics and biosimilars, the company has joined forces with Premier Health, a healthcare company uniting approximately 3,750 U.S. hospitals and 130,000 other providers. “This partnership will enable us to talk to doctors about biosimilars to give them a level of familiarity and comfort with them,” Mohan explained. Such collaborations could also enable marketing advantages, such as private pharmacy labels, for the company in the future.

Even though its adalimumab candidate is not yet on the market, Oncobiologics has plans to begin its educational strategy. The company will present data from the Phase 1, and eventually the Phase 3 data, in order to start making physicians more comfortable with that data. Mohan said, “The goal is to work toward establishing a common understanding about the science behind our biosimilars before our product is on the market.”

What Should We Expect From Interchangeability?

Mohan believes interchangeability will be the driving force behind biosimilar uptake. Once the FDA guidance is released, there will be no stopping companies — both small and large — from seeking the designation. After all, this designation promises access to a greater portion of the market and quicker erosion of the innovator’s market share. “You can more easily convert existing biologics patients to a biosimilar once it has been declared interchangeable by the FDA and boasts a higher discount,” Mohan explained. “If the discount is small and it’s not interchangeable, you’re more likely to get only new patients coming into the disease area.”

However, it is yet to be determined if interchangeability designations will be common, or even accepted, across all classes of treatment. For instance, when it comes to drugs that are used over long periods of time, such as Humira, interchangeability could significantly cut down on long-term treatment costs. On the other hand, drugs in the oncology space, such as Herceptin and Avastin, may only be taken for six months to a year. “Interchangeability may be less desirable in oncology, because switching in the middle of a three-month treatment may be less convenient, especially when it comes to life-saving drugs,” Mohan offered.