The Biosimilars Council: Why Trade Organizations Are Key For Biosimilars
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
As the biosimilar market in the U.S. develops, a growing number of biopharma companies are stepping forward to shape the policies that will impact the market’s growth. Many of these companies, whether they be big pharma, generics and biotech companies, and/or pure-play biosimilar companies, are becoming members of a number of trade organizations that have been cropping up over the past year. One of these groups is the Biosimilars Council, a division of the GPhA.
The council has 12 members, including Biocon, Dr. Reddy’s Laboratories, Momenta Pharmaceuticals, Mylan, Pfenex, Sandoz, and Teva. According to Dr. Bert Liang, chairman of The Biosimilars Council and CEO of biosimilar company Pfenex, the council was formed to be a support system for the burgeoning biosimilar market in the U.S. As Liang describes, “The members of the GPhA board realized the fledging biosimilar market needed some level of representation. These interests were well aligned with the generics mindset, as opposed to branded companies which typically had been associated with organizations like BIO. There needed to be representation around current issues, and this had to come from companies that were predominantly biosimilar companies, as opposed to more hybrid companies that had a number of different business units.”
Following meetings between company leaders and members of the GPhA, the Biosimilars Council launched in April 2015. Several months later, Liang was appointed as the Council’s inaugural chair.
How History Impacted The Council’s Educational Strategy
Following Sandoz’s approval of Zarxio in March 2015, it became clear there needed to be a support network for companies that would be the drivers of the biosimilar market. As Liang describes, the primary goals for the Council are not just focused on the business aspect of market formation and the evolution of the regulatory pathways. “We are spending a lot of time and resources on education,” Liang offers. There is a need for education about emerging policies inside the beltway and in state capitols. But healthcare providers also need to be more informed about biosimilars. “We’re hoping to partner with the regulatory bodies, such as the FDA, to familiarize providers with biosimilars,” Liang says.
The safety of biosimilars has been one of the biggest concerns of the healthcare community. This is why it’s important to emphasize the regulations that exist for biosimilar approval. The science behind these products can be intimidating, Liang admits. “There’s a significant amount of science behind these treatments. But because of this complexity, there are no shortcuts within the regulatory review for biosimilars either,” he says.
When the generics market was launched a few decades ago, the FDA created an educational platform to teach doctors about these emerging treatments. While it might seem that the biosimilar educational platform could be modeled after that of generics, Liang says there are a few key differences that have differentiated the Council’s work from that of small molecule generics groups. He acknowledges that it’s important to initially target the doctors with your educational efforts, in the same way generics companies did to encourage uptake of small molecule generics decades ago. After all, doctors are the “gatekeepers” to the marketplace. But the biosimilar industry also has Europe’s 10 years of experience to use as a key resource. This provides biosimilar makers with more detailed and sophisticated information on patients’ biosimilar experiences abroad.
Another key difference is how the 351(k) pathway is being formed. For instance, as Liang explains, there’s been a lot of focus placed on making sure the 351(k) pathway is meaningful for the clinician. For instance, little information is shared with the clinician about the generic approval process via Hatch-Waxman. Indeed, a generic drug’s label is the same as the originator drug, and the brand’s international nonproprietary name (INN), without any changes or suffixes, is used on a generic drug’s label. The FDA recently issued a draft guidance on biosimilar labeling that permits the use of the reference product’s data, rather than comparative data generated by the biosimilar product sponser, in the label. However, there will still be a biosimilarity statement. This statement will inform the doctor and patient that the treatment is a biosimilar to a specific reference product. Similarly, if the biosimilar was not approved for every indication as the reference, the label will also designate this difference.
The Council has also focused closely on how European countries have educated doctors and encouraged biosimilar use. Liang references Germany in particular, which has a decentralized mechanism to pay for pharmaceuticals, similar to the U.S. “What we have seen and heard is that there has to be a partnership between the regulatory bodies and payers, as well as with industry,” he says. “If you have those partnerships, then physicians understand what the end game is.”
What Are The Council’s Current Priorities?
Besides educating providers, Liang says the Council is dedicating resources to address the Biosimilar User Fee Act (BsUFA) reauthorization, or BsUFA II. These negotiations have been underway for several months. The Biosimilars Council, along with other industry organizations like PhRMA, BIO, and The Biosimilars Forum, is calling for a more timely and transparent biosimilar review process. “We need to get more transparency into how the BsUFA dollars are being spent,” Liang argues. Similarly, the reauthorization can help ensure the FDA has the appropriate number of resources to carry out reviews and to draft and release FDA guidance documents. “The BsUFA reauthorization negotiations are key to streamlining biosimilar development programs,” says Liang.
Other central players in biosimilar uptake in the U.S. are the individual states. In the U.S., biosimilar substitution policy is determined by the state. There are 19 states that have passed legislation supporting biosimilar substitution. But there is still a lot of work to be done to educate officials at the state level. As Liang says, the council is working with federal and state stakeholders to bolster biosimilar accessibility at the state level. “There’s no easy mechanism to determine substitutability, like an Orange Book,” offers Liang. “State capitols and stakeholders have to explore other mechanisms for this. In many cases, this will involve new legislation.”
The Fundamental Question For Biosimilar Makers
As Liang acknowledges, the U.S. is currently home to two biosimilar-specific organizations: The Biosimilars Council and The Biosimilars Forum. In addition, PhRMA , BIO, and the GPhA are also playing roles in the development of policy and education for the burgeoning market. Though this is a wide number of parties, all of which have varying memberships and differences in opinion over policies, Liang says this is typical of a nascent industry. When the generics industry launched, there were four organizations that came forth to support the industry. “It’s not uncommon that you’ll have different trade groups representing different constituencies when fledgling industries come up,” says Liang. “We can’t make a prediction of how, when, or even if there will ever be consolidation amongst biosimilar organizations. But if history tells us anything, there should be.”
There are many different companies and opinions circulating within the U.S. as the country develops policies and fine-tunes the regulatory pathway. Even within The Council, Liang says, individual companies have different views. As such, there will always be some level of differences in opinion over issues. But as Liang says, “We try to transcend that by asking the fundamental question: What is the best thing for the industry? The differences in business models among biosimilar companies shouldn’t transcend doing what is best for the industry. That’s something we should not ignore going forward, either as participants within the industry or as we speak with our stakeholder colleagues.”