In her presentation at the 2021 Academy of Managed Care Pharmacy Nexus meeting, Aimee Tharaldson, PhD, highlighted the most anticipated specialty pharmaceutical drugs awaiting FDA approval, including several treatments for cancer and rare diseases.
During her presentation at the 2021 Academy of Managed Care Pharmacy Nexus meeting, Aimee Tharaldson, PhD, Senior Clinical Pharmacist of Emerging Therapies at Express Scripts, highlighted the most anticipated specialty pharmacy drugs awaiting approval by the FDA, including a number of treatments for cancer and rare diseases. as well as gene therapies.
Tharaldson identified specialty drugs that may receive FDA approval or new indications within the next 12 months and pointed out the likely effect of these new specialty drugs in this managed care market.
Currently, 31 specialty drugs have been approved in 2021, with 8 more expected to be approved by the end of the year, paving the way for potential competition with the 39 approvals granted in 2020.
A big topic of discussion was the potential of biosimilars, which represents a $ 61 billion opportunity for manufacturers. By 2025, 98 patents are expected to expire, including those of Humira (adalimumab), Stelara (ustekinumab), Eylea (etanercept) and Prolia (denosumab).
Tharaldson mentioned 13 biosimilars pending approval, some of which refer to Humira, Avastin (bevacizumab), Neupogen (filgrastim), Novolog (insulin aspart), Neulasta (pegfilgrastim) and Lucentis (ranibizumab).
Tharaldson explained that about 17 million Americans have a history of cancer and nearly 2 million new cases of cancer are diagnosed each year. In 2020, 19 cancer drugs were approved, which was a new record of approvals. So far, in 2021, 15 have been approved, and 2 more are expected to receive approval by the end of November 2021.
Tharaldson mentioned 6 cancer drugs expected to be approved in the first quarter of 2022, including new drugs to treat neuroendocrine tumors, uveal melanoma, chronic myeloid leukemia, melanoma, chronic lymphocytic leukemia, and non-small cell lung cancer.
As of October 2021, 9 of the drugs approved during the year were indicated for orphan conditions. Of all the drugs that are currently in the specialty drug pipeline, 47% are indicated for orphan conditions, compared to 31% for oncology and 22% for other conditions.
Gene therapies involve altering a person’s genes to treat or cure a disease. Tharaldson said there are around 400 gene and cell therapies underway and the market is expected to generate $ 25 billion annually by 2034.
There are currently 9 gene therapies that were approved between 2010 and 2021, and 9 more are expected to receive approval by 2022, including Janssen’s ciltacabtagene autoleucel, which is expected to receive approval as of November 29, 2021.
The inflammatory pipeline currently contains 8 drugs, 4 of which have already been approved but are expected to gain new indications for psoriatic arthritis, ankylosing spondylitis, Crohn’s disease or alopecia areata. Additionally, approval of bimekizumab, a psoriasis drug slated for approval in 2021, has been postponed due to manufacturer UCB receiving a full response letter from the FDA requiring it to perform additional testing. .
Tharaldson explained that the atopic dermatitis pipeline to 2023 has 7 drugs awaiting approval, of which 4 will be administered orally and the other 3 will be administered subcutaneously.
By 2025, the multiple sclerosis space is expected to have approvals for 5 new drugs, 4 of which can be administered orally and are Bruton tyrosine kinase inhibitors. The outlier, ublituximab, is expected to be approved in 2022 and is the only CD-20 monoclonal antibody inhibitor currently in development.
Tharaldson said that 95% adherence is necessary to maintain viral suppression of HIV, which is why the most widely used drugs rely on daily intake. However, ViiV Healthcare is seeking updated approval for its cabotegravir / rilpivrine to be administered every 2 months instead of every 1 month, which is expected in December 2021.
Of the 5 products pending approval, all are for injectable formulations, with the exception of Merck’s islatravir, which is delivered orally and is expected to be approved in 2022.
Non-alcoholic steatohepatitis (NASH)
According to Tharaldson, NASH is thought to impact between 6 and 19 million Americans, and treatment options are limited. The treatment space is expected to grow significantly in the coming years, with 13 products awaiting approval between 2023 and 2024. Ultimately, the NASH therapeutics market is expected to generate $ 20 billion annually as the space expands. treatment is developing.
The Alzheimer’s disease pipeline currently has 5 drugs pending approval, with 3 beta-amyloid antibodies expected to be approved in 2022 or 2023 and 2 anti-tau antibodies expected to be approved in 2024, Tharaldson said. Alzheimer’s disease is estimated to affect 6.2 million Americans.
Although Aduhelm (aducanumab-avwa) was approved in June 2021, the approval has sparked great controversy as data has shown the possibility that the drug may not work as well as previously disclosed.
Tharaldson identified 9 drugs that are expected to receive FDA approval between 2022 and 2023, of which 5 are indicated for hemophilia A only, 2 are indicated for hemophilia B only, and 2 are indicated for hemophilia A. types A and B. The two drugs indicated for hemophilia A and B are given by subcutaneous injection; while the others are all intended for intravenous infusion. Hemophilia A is the most common type of hemophilia, estimated to account for about 80% of hemophilia cases.