How Will AbbVie, J&J, And Amgen Handle The Biosimilar Age?

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

Following the approval of the first biosimilar last week, there were a number of questions circulating throughout the industry. My blog from last week addressed two questions about where the biosimilars market is headed, but I also wanted to address a third question I’ve seen cropping up: What are companies with blockbusters going to do to keep revenues intact now that they’re facing biosimilar competition?

According to Bidness etc., an FDA spokeswoman says the FDA has been in discussions with companies regarding upwards of 50 biosimilars that stand to threaten the financial wellbeing of 15 different biologics. Humira (AbbVie), Remicade (Johnson & Johnson), and Enbrel (Amgen) are three big biologics expected to be hit hard by future biosimilars. Given Sandoz’s approval of Zarzio (Amgen’s Neupogen), the immediate concern should perhaps be what Amgen plans to do now.

Amgen

According to Bloomberg, Amgen could see $7 billion of its revenue lost due to Sandoz’s recent success. Let’s not forget, the company is also looking at biosimilar competition for its $5.1 billion drug Enbrel for arthritis and its Neulasta, worth $3.83 billion. In fact, Neupogen and Enbrel brought revenue up to $20 billion in revenue this year. The company certainly has a lot to lose. However, given some of the news I’ve come across lately about what this player has in the works, I dare say it’s feeling optimistic about its prospects.

Amgen is also working on its own biosimilars. According to Bloomberg, there are eight biosimilars in development at its Thousand Oaks facility, five of which it hopes to have on the market by 2019, with expectations of earning $3 billion per drug. The biosimilar for AbbVie’s Humira is currently the furthest in testing.

In addition to biosimilars, Amgen is undergoing some restructuring to enhance its presence in the oncology field, The Pacific Business Times reports. The company plans to relocate its oncology division from San Francisco to its Thousand Oaks facility. The key player in its possession is subsidiary Onyx’s Kyprolis, which recently beat out rival Velcade in a Phase 3 trial for relapsed multiple myeloma.

Like many others in the industry as of late, I’m also expecting the company could be facing a surge in revenue if its work in the cholesterol space keeps progressing. Amgen announced some good news about Repatha (evolocumab), its PCSK9 inhibitor for lowering cholesterol. In the OSLER-1 and OSLER-2 clinical trials, the drug plus standard-of-care lowered cholesterol by 61 percent. However, data also suggests the drug could reduce the rate of cardiovascular events. After one year of treatment, the rate of cardiovascular events was .95 percent for patients taking evolocumab compared to 2.18 percent in the control group. But the drug’s true effect on cardiovascular health cannot quite be determined yet from this data; the ongoing FOURIER trial, which is investigating evolocumab’s effect on cardiovascular health, will be the true test.

This news has been a big talking point the past few days, especially since Sanofi and Regeneron just announced similar positive results for their own PCSK9 inhibitor Praluent (alirocumab) in the ODYSSEY trials. Sanofi and Regeneron recently submitted an application to the FDA, pending a final decision in late July. There is already some gossip about a future price war occurring between Praluent and Repatha, especially given the similarities between the two drugs. We very well could be witnessing another battle comparable to that between Gilead and AbbVie.  Speaking of…  

AbbVie

I’ve written about AbbVie’s Humira before, as it is, arguably, the drug the industry is most concerned about in the face of biosimilars — a worry that is certainly founded, given it’s a particularly impressive drug. Boasting a whopping eight indications, the drug raked in around $14 billion in sales last year. But, important to note, the drug is still safe until 2016 (with some rumors its multiple indications could push back patent expiration a bit). It could also take a while for a biosimilar to get approval and become popular in the market. (As a Thomson Reuters Bio World expert in this Life Science Leader article describes, there is an “uneven” regulatory landscape for biosimilars, which leaves a company uncertain “going in about how many steps they are going to have to go through.”)

If analysts are accurate, they’ve pegged 2018 as the year AbbVie will see a large chunk (60 percent) of its Humira revenue stolen away by biosimilars. Amgen, Novartis, Boehringer Ingelheim, and Pfizer are all pursuing their own biosimilars for Humira, says Bidness etc.

Like Amgen, it sounds like AbbVie is well on its way to new sources of income. While the company isn’t currently making its own biosimilars, it has its high-profile Viekira Pak hep C candidate in its portfolio and made a recent deal to buy oncology drug maker Pharmacyclics and its impressive cancer drug Imbruvica — expected to bring in peak sales of $3.6 billion.

There’s even recent speculation about AbbVie considering an acquisition of its partner Galapagos, which is currently testing filgotinib (GLPG0634), an experimental oral treatment that could turn out to be a big player in the $27 billion rheumatoid arthritis market.

Johnson & Johnson

Johnson & Johnson’s Remicade brought the company $6.9 billion in revenue last year, making it, along with Humira, one of the top-selling drugs of 2014. The company will be losing its patent in 2018, so there are still a few years of exclusivity. But the company is, of course, still eying its pipeline, and like AbbVie, took a fancy to Pharmacyclics, with which it co-markets Imbruvica. We know how that turned out for J&J, but the company doesn’t seem to be fazed. While it hasn’t been confirmed, there are rumors that J&J, like AbbVie, could also have its eyes on Galapagos as a potential acquisition, says Bloomberg.

However, should butting heads with AbbVie for acquisitions not work out in the long run, the company is also covering its drug discovery bases. Just a few weeks ago, J&J launched its JLABS@San Francisco incubator. The space will eventually house 50 startups and provide them with the tools and collaborative environment to foster innovation and discovery. While the press release says there are “no strings attached” for those using the lab, it wouldn’t surprise me if this collection of startups serves as a good way for the company to find future partners and molecules in order to keep its pipeline growing.