As patents expire, the biggest names in pharmaceuticals are seeing an end to their solid run with holding exclusivity on biologic drug treatments[GG1] . Patent expiries have been trickling in over the last few years, and big pharma is scrambling to make up for the billions in lost revenue, which is sure to increase significantly in the coming years as competition heats up. Pharma giants can take steps to maintain some exclusivity on their patents, but they may soon run into trouble where intellectual property and competition laws are concerned.

Global sales of biologics are rising at a rate of 5.5 percent per year—as a reference point, the entire pharmaceutical industry is currently growing at annual rate of 1.9 percent. Due to the industry’s success, other drug manufacturers are eager to gain entry into the space by developing biosimilars meant to treat the same conditions as the reference products.

Humira, Benepali and More: The Race is On

AbbVie believes their drug Humira, which boasts $13 billion in annual sales, is immune to the threat of competition until 2022 when the drug officially goes off patent. However, Amgen filed an application for their own version just last week and is in the process of fighting two of AbbVie’s patents on the drug, which treats rheumatoid arthritis and plaque psoriasis.

If successful, Amgen’s biosimilar drug could be on the market as early as 2017. Amgen is playing both sides of the coin; they are currently in the midst of fighting three different lawsuits to protect their own originator biologic treatments against biosimilars, while simultaneously working to bring five of their own biosimilars to market. If regulators rule in favor of biosimilars, Amgen stands to own a significant slice of the biosimilar pie, yet will be competing with itself in short order.[GG2] 

Humira, one of the world’s most popular drugs, is already being heavily targeted by companies angling to make an entrance into the burgeoning U.S. marketplace. The Amgen application was backed by a 24-week clinical trial, with phase 3 data demonstrating interchangeability between their biosimilar and Humira. Amgen is seeking two indications, rheumatoid arthritis and plaque psoriasis, while Humira has four, adding psoriatic arthritis and ankylosing spondylitis to the list. It remains to be seen whether other developers will do the same as they begin submitting applications.

Meanwhile, in the European Union[GG3] —the European Medicines Agency approved Benepali in November. The first approved biosimilar of Enbrel, Benepali, is on schedule to launch in early 2016. Another hugely popular treatment, Pfizer’s Enbrel went off patent in back in August, which opened up the playing field to competitors.

The EU Factor: Consumer Uptake on the Up and Up

Since 2006, biosimilar uptake has been on the rise in the EU, with wider patient adoption with each passing year. In the EU, the average cost savings of opting to use a biosimilar versus a branded drug is roughly 35 percent, as compared to the Federal Trade Commission's projected 10 to 30 percent discount in the fledgling U.S. market.

While the Food and Drug Administration has a set of processes in place in order to determine interchangeability on any given biosimilar, the European Medicines Agency does not, which makes it easier to bring alternative treatments to market. The EMA recently updated their guidelines so substitution policies are done on a country-by-country basis.

However, once the pathway to biosimilar approval becomes more finely tuned, the increased competition could create further discounts. In Norway, for instance, some drugs were discounted by 70 percent [GG4] . The U.S. and the rest of the EU could see similar effects as the 10-plus Humira copycats in development make their way to market.

Looking Ahead—How Will Heightened Competition Impact the Pharmaceutical Market?

According to a report by Bloomberg Intelligence, biosimilars pose a threat to over $190 billion in global pharmaceutical sales over the course of the next decade, and copies of Humira, Remicade, Neupogen, Neulasta and Enbrel are likely to be the most affected. Competition is quickly working its way up the pipeline, but major players, such as Amgen in particular, could potentially monopolize the space. However, several other companies are playing catch up; Baxalta and Momenta are planning to submit their versions of Humira in 2017, while Merck, Samsung Bioepis and Novartis have their own follow-on biologics in the works.

Patient access will likely improve, but it remains to be seen how FDA approvals, Centers for Medicare & Medicaid Services regulations, pricing, naming and other issues will shake out. Obviously, discounts will amount to increased adoption no matter what but pricing could still be an issue.