2016 Drug Pipeline Full of Blockbuster Potential

Mar 24, 2016
2016 is expected to be a big year for first-time generics, with an estimated $20 billion targeted for going generic.

New Pills

With several name brand drugs falling off patent, new biosimilars potentially gaining approval, and new treatments for cancer, diabetes and hepatitis C, 2016 is shaping up to be a blockbuster year for drugs to gain approval from the U.S. Food & Drug Administration.

2016 is expected to be a big year for first-time generics, with an estimated $20 billion targeted for going generic.

On Feb. 1, Sun launched a generic to Gleevec® (imatinib mesylate), a drug first approved in 2001 for treating Philadelphia chromosome positive (Ph+) chronic myeloid leukemia. It is also approved to treat certain patients with Ph+ acute lymphoblastic leukemia, myelodysplastic/myeloproliferative diseases, aggressive systemic mastocytosis, hypereosinophilic syndrome/chronic eosinophilic leukemia and dermatofibrosarcoma protuberans. Gleevec produced $2.5 billion in sales in 2015. Sun was granted 180 days of generic exclusivity, preventing the FDA from approving additional generics until late-July 2016.

Billion-Dollar Products Coming Off Patent in 2016

2016 Patent Expirations

Oncology Outlook

Several breakthrough cancer therapies may reach the market in 2016, following the trends of recent years. Under FDA guidelines established in July 2012, drugs designated as breakthrough therapies undergo an expedited development and review process. In order to achieve the designation as a breakthrough therapy, a drug must meet the criteria that it is intended to treat a serious or life-threatening condition and that preliminary clinical evidence shows the drug may demonstrate substantial improvement over existing therapies.

Medications being designated as breakthrough therapies greatly expedites the process and opens doors for patients who previously had limited treatment options.

Key oncology drugs expected to gain approval this year include:

  • Atezolizumab (Genentech) – an infused drug that may be approved for non-small cell lung cancer and bladder cancer
  • Entinostat (Syndax Pharmaceuticals) – an oral medication for certain types of breast cancer
  • Venetoclax (AbbVie/Genentech) – an oral treatment for certain patients with chronic lymphocytic leukemia

More Competition for Hepatitis C

On Jan. 28, Merck received FDA approval for ZepatierTM (elbasvir/grazoprevir) for the treatment of adult patients with chronic hepatitis C virus genotype 1 or genotype 4. Gilead is expected to gain approval in June for sofosbuvir/velpatasvir, a single tablet for genotypes 1 through 6.

This will be the first pan-genotypic regimen. These newly approved drugs will increase competition while providing additional cure options for this chronic disease. The standard of care for treating patients with hepatitis C has evolved rapidly over the past few years.

Potential Biosimilar Windfall

Biosimilars officially reached the U.S. in 2015, when the FDA approved ZarxioTM (filgrastim-sndz), a biosimilar product produced by Sandoz. The drug will compete with Amgen’s Neupogen® (filgrastim) – a blockbuster treatment used to decrease rates of infection in certain cancer patients during chemotherapy.

Things in the biosimilar market could heat up this year with seven new biosimilar drugs under FDA review, with several offering new treatment options for patients with rheumatoid arthritis and psoriasis.

Biosimilars have the potential to significantly lower the cost for safe and effective treatments for patients.

Inflectra, a biosimilar to Remicade® (infliximab), may gain approval as early as June and would be the first monoclonal antibody biosimilar. It could be indicated in all uses approved for Remicade, including rheumatoid arthritis, psoriasis, psoriatic arthritis, Crohn’s disease, ulcerative colitis and ankylosing spondylitis. Remicade U.S. sales totaled $4.5 billion last year.

Etanercept a biosimilar to Enbrel® (etanercept), could gain approval as early as June and can be used to treat a range of immunological diseases including rheumatoid arthritis and psoriasis. Adalimumab, a biosimilar to Humira® (Adalimumab), has an FDA action date in September and will also provide an alternative treatment for patients with moderate to severe plaque psoriasis and rheumatoid arthritis.

Although FDA action dates are set, ongoing patent litigation dispute between the biosimilar and brand manufacturers will likely delay the availability of these drugs.

Continued Development of Diabetes Treatments

Among traditional drugs, the treatment of Type 2 diabetes will also see increased competition within existing drug classes.

As the most common form of the disease, Type 2 diabetes affects about 24 million people and accounts for more than 90% of diabetes cases diagnosed in the U.S. At least four new diabetes drugs could gain FDA approval this year, representing increased treatment options for millions of Americans.

Diabetes drugs that could gain approval in 2016 include:

  • Lyxumia
  • Lixilan
  • Xultophy
  • Basaglar
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