What Biosimilar Makers Need To Know About 2016
By Anna Rose Welch, Editorial & Community Director, Advancing RNA
Welcome to 2016! Over the past couple of weeks, I’ve been reading the customary slew of end-of-the-year big industry event roundups and experts’ predictions for the new year. As I continue to charge further into the developing biosimilar market, I’ve been reading these predictions and getting my hands on industry reports to get a better picture of what biologics and biosimilar makers should expect in 2016. Here’s my rundown of what I think will be important to keep in mind in 2016 as the biosimilar market continues to unfold.
FDA Approvals Suggest Biologics “Tidal Wave” Coming Closer
First off, I think it’s important to take note of the FDA’s productive year. Last year, the industry was reeling over the news the FDA had approved 41 drugs in 2014. In fact, 2014 was declared the best year for approvals since 1996, which saw 53 drug approvals. However, 2015 came out a cut above 2014. The FDA approved 45 new drugs through its Center for Drug Evaluation and Research (CDER). Of the new drugs approved in 2015, 15, or 31 percent, were biologics, BIO reports. I’ve heard rumors there’s a biologics tidal wave heading for the industry. Indeed, the biologics approval rating increased since 2014. According to PharmTech, in 2014, biologics comprised 25 percent, or 10, of the 35 drugs approved by the Center for Drug Evaluation and Research (CDER). Based on these numbers, this wave is crawling ever closer.
What Will 2016 Bring For Biologics And Biosimilars?
In keeping with the rise in biologics approvals last year, 2016 is looking to be a good year for the biopharma sector. The Evaluate Pharma Vantage (EP Vantage) 2016 Preview report forecasts continued R&D productivity. Analysts predict 2016 will feature the launch of as many as 12 new drugs that are expected to become blockbusters by 2020. Obviously, it will be quite some time before we see biosimilars for any newcomer biologics in 2016. But for those invested in biosimilar development now, the predictions for top 10 drug sales in 2016 are owned by many of the current biosimilar prospects. This chart is no doubt daunting news for the reference product sponsors because it highlights just how much in sales they stand to lose from biosimilar competition. But this certainly bodes well for biosimilar makers looking to gain their own portions of this illustrious market share.
No surprise here, forecasted to come in first place for sales in 2016 is AbbVie’s Humira. This wonder-biologic is expected to bring in $15.7 billion in worldwide sales in 2016. In third place (behind Gilead’s Harvoni at $11.6 billion) is Roche’s Rituxan ($7.3 billion), followed by Avastin ($7 billion), Sanofi’s Lantus ($6.9 billion), and Roche’s Herceptin ($6.8 billion) in sixth place. Almost bringing up the rear in ninth place is Janssen’s Remicade ($5.8 billion), perhaps because of the increasing use of infliximab biosimilars in Europe, says EP Vantage. Biosimilar competition for Lantus — Lilly’s Basaglar — is not expected to be a huge threat for Sanofi in 2016. However, competition from both Basaglar and Novo Nordisk’s long-acting insulin Tresiba did lead to a decrease in the forecasted 2016 worldwide sales for Lantus ($6.9 billion), down from $7.4 billion in 2015.
Will Innovators Be Unfazed By Biosimilars?
I’ve been increasingly focused on how companies have been responding to the threat of biosimilar competition. Obviously, some innovator companies, such as Amgen and Biogen, have decided to approach the threat of biosimilars by making their own. However, one of the biggest pieces of news in 2015 that intrigued and surprised me was AbbVie’s announcement that it would not be pursuing biosimilar development as a way to supplement any losses from competition to Humira. Rather, the company is more interested in bringing innovative drugs to market. And it looks like their goals will be realized in 2016. Venetoclax for blood cancer and Elagolix for endometriosis have been pegged by EP Vantage as two of the 10 biggest drug launches in 2016. These products will not bring in the amount of money the company will need to even come close to replacing Humira revenues. Together, the two are expected to bring in $2.1 billion in 2016. But the company has been adamant that its 70-plus patents on Humira will keep competition at bay until at least 2022. If that becomes the case, the sales for Venetoclax and Elagolix, while expected to bring in smaller sales numbers in 2016, could see greater growth in upcoming years. It’s also hard to believe the company won’t have any other new launches in the next six years, especially since it’s determined to compete against biosimilars without jumping into the biosimilar game.
Roche is another company facing a big threat from biosimilars. The company currently has three products in the top 10 ranking for worldwide sales revenues. While none of these three individually are bringing in as many billions as Humira is on its own, the three products together — Rituxan, Avastin, and Herceptin — stand to bring Roche upwards of $21 billion in 2016. Like AbbVie, the company is expected to bring two new biologics to market: Atezolizumab for non-small cell lung cancer and bladder cancer and Ocrelizumab for multiple sclerosis. These two are pegged to be in second and third place of the 10 biggest launches in 2016, earning Roche a combined $5 billion in sales.
Roche has also turned to the development of more convenient administration methods for existing biologics and more effective second-generation products. Indeed, as FirstWord Pharma’s Duncan Emerton wrote in a blog post two years ago, rituximab is now also faced with competition from Roche’s next generation anti-CD20 mAb Gazyva. And this competition could win over doctors and make them overlook rituximab biosimilars. In fact, Gazyva in combination with chlorambucil was more effective than rituximab plus chlorambucil in its CLL11 clinical trial for chronic lymphocytic leukemia. However, despite the potential allure of Gazyva, Celltrion has still taken the plunge and submitted a marketing authorization application to the European Medicines Agency (EMA) for its rituximab biosimilar (CT-P10). I’ll definitely be keeping my eyes open for this decision in 2016, as I’ve heard no other recent updates on how other companies are faring with their rituximab development programs.
Industry Predictions For Biosimilar Market Growth In 2016
As I mentioned previously, biologics are expected to take pharma by storm in the next few years. 2015 revealed a continued increase in the number of biologics being approved for the market. Biosimilars will only increase the impact of this tidal wave on the industry. In fact, as Bert Liang, CEO of Pfenex, told BioPharma DIVE, 2016 will see “small molecule generics companies considering biosimilar investment as a growth engine that drives innovation, lowers costs, and increases access.”
This being said, there is still a ways to go before the U.S. biosimilar market takes off. In an interview for a Life Science Leader article, Craig Wheeler, CEO of Momenta Pharmaceuticals, told me biosimilar market growth will be “evolutionary” rather than “revolutionary.” And this seems to be a shared argument of many in the industry. BioPharma-Reporter recently featured an interview with Andrew Williams, a partner with McDonnell Boehnen Hulbert & Berghoff LLP, in which Williams argues that the rise in the number of clinical trials and biosimilar applications to the FDA suggests we could see a “spate of biosimilars breaking through in 2016.” But it will all come down to the amount of time it takes the FDA to review applications. According to Williams, should a complex molecule such as Amgen’s biosimilar for Humira be approved as quickly as Sandoz’s Zarxio, we could see the U.S. market take several bigger strides in 2016. However, it’s still unclear how much data a company will need to demonstrate its biosimilar has no clinically meaningful differences from the reference product. Williams also says looking to Zarxio as an example of what could become the typical FDA biosimilar approval process is tricky. It’s hard to know for sure whether the drug made it more quickly through the FDA approval process because the treatment was already approved in Europe and, therefore, had a great amount of data supporting its efficacy.
I’m excited to witness the growth of the global biosimilar market in the upcoming year. Here in the U.S., I expect we’ll see more approvals for biosimilars, and I know many are holding their breath to hear what the FDA has to say about Amgen’s first biosimilar of Humira. Overall, I expect that we’ll see more companies teaming up for biosimilar development, as well as new companies coming out of the woodwork. And I’m looking forward to having conversations with a number of these players in the months ahead to be able to share how companies are forging their own business models and paths in this exciting new space.