Specialty Pharmaceutical Pipeline: Increased Competition, Biosimilar Uncertainty

Perennial favorite, Aimee Tharaldson, PharmD, senior clinical consultant of emerging therapeutics at Express Scripts, opened the Academy of Managed Care Pharmacy 2016 Nexus, October 3, 2016, in National Harbor, Maryland, with a discussion of specialty pharmaceutical drugs in the pipeline.

During the first session of the conference, Tharaldson outlined the increased competition in the specialty drug space, the state of biosimilars, and the specialty drug pipeline.

Overall, competition in the specialty drug space has increased, and the introduction of biosimilars will add to the competition. However, there is still a lot that is unknown regarding biosimilars, Tharaldson said.

While the FDA has approved 4 biosimilars, there is a lot of litigation surrounding the launch of biosimilars and an interchangeability rule is still pending.

Litigation is one of the biggest hurdles for biosimilars coming to market. Inflectra was approved in April 2016 and October 3, 2016, represented the 180-day wait period that the FDA requires between approval and market launch. However, the biosimilar is still tied up in litigation as Janssen alleges that patents on Remicade are still valid. Erelzi, approved in August 2016, will also likely be delayed. Tharaldson expects that the biosimilar of Amgen’s Enbrel likely won’t come to market for another 2 or 3 years.

Finally, a biosimilar for AbbVie’s Humira was just approved, but AbbVie seems confident that the 60 to 70 patents it has will protect its product until 2022 or even 2025, she added.

In addition, there are another 5 biosimilars pending approval with the FDA.

Orphan Drug Development

While there has been a lot of focus on cancer medication, there has been even more on orphan drugs, said Tharaldson. Cancer drugs (non-orphan status) account for 22% of the specialty drug pipeline. In comparison, orphan drugs account for 40% of the specialty pipeline.

The leading specialty classes last year by drug spend were inflammatory conditions, multiple sclerosis (MS), cancer, hepatitis C, and HIV. In the past 6 years, the FDA has approved more specialty medications than traditional medications and with the 7 years of marketing exclusivity and other incentives, orphan drugs are a lucrative business, she said.

Multiple Sclerosis

The current options available for multiple sclerosis include immunodulators, monoclonal antibodies, and oral therapies. The pipeline is showing a lot of development for patients with progressive MS, which currently has no approved treatments available.

In addition, there may be a generic version of copaxone 40 mg approved next year, but other oral drugs in the pipeline likely wont’ reach the market for at least 2 years, Tharaldson said. However, even in this area, litigation is an issue.

“Even if generic copaxone is approved in February of next year, it likely won’t reach market until 2019 due to pending litigation,” she explained.

The first drug up for approval in MS is Ocrevus from Genentech, which will be the first drug for progressive MS. It is an IV infusion every 6 months and has shown to be very effective with annualized relapse rates reduced by 40%, Tharaldson said.

Cancer

Tharaldson expects more breakthrough therapies to be approved for cancer with drugs getting to the market more quickly. She added that in the next 10 years, it’s expected that half of all cancer treatments will be used with immunotherapies.

Some of the cancer drugs pending approval that Tharaldson highlighted were:

Olaratumab: a biologic for advanced soft tissue sarcoma, a disease with limited treatment options. The clinical trials showed the drug was effective in improving both progression free survival and overall survival.

Rucaparib: a treatment for advanced refractory BRCA+ ovarian cancer. There are only 22,000 new cases of ovarian cancer in the United States each year and of those just 10% are BRCA+.

Neratinib: a treatment for early-stage breast cancer patients who are HER2+. Right now the clinical data shows neratinib causes a lot of diarrhea in patients, so the FDA may want to wait until more data is available.

Farther Out: Alzheimer’s Disease and NASH

The pipeline drugs for Alzheimer’s disease won’t come to market until 2018 at the earliest. While 5.4 million Americans have Alzheimer’s disease, there aren’t any disease-modifying drugs available just yet. The options that are available treat symptoms.

There are currently 9 drugs in the pipeline for Alzheimer’s disease and Merck’s verubecestat is the farthest along in development.

Another disease area where there are a lot of drugs in development, but the first ones won’t come to market for another couple of a years is nonalcoholic steatoheaptitis (NASH). There are 6 to 16 million Americans with NASH and it is primarily associated with the rise in obesity.

Patients may have NASH if they have fat in the liver along with liver inflammation and liver damage. Currently, patients with NASH have very limited options: lose weight, switch to a healthier diet, exercise more, avoid alcohol, and treat the concurrent conditions.

There are 3 NASH drugs in phase 3 trials, but they won’t start reaching the market until 2019.

“There’s a lot of interest,” Tharaldson said. “A huge patient population. Some analysts project that this could be a $35 billion market.”