Pfizer To Launch Several Drugs Despite Generic Headwinds

Pfizer, Inc. PFE expects continued strong growth of key product franchises, including Ibrance, Eliquis, Xeljanz and Prevnar. However, loss of exclusivity (LOE) on key drugs in the United States is expected to hurt 2019 sales significantly, including the expected LOE of key drug Lyrica in the United States in June 2019. In fact, loss of exclusivities hurt 2017 sales by $2.1B and 2018 sales by $1.8B. It is expected to hurt 2019 sales by $2.6B including the expected LOE of Lyrica. Some other products like Chantix and Sutent will lose exclusivity in the country in the next couple of years.

Also, currency headwinds are expected to significantly pull down 2019 revenues.Other top-line headwinds include weak sales in the sterile injectables portfolio, pricing pressure and rising competition.

Pfizer’s sterile injectables portfolio has been seeing lower revenues since the past few quarters due to continued legacy Hospira product shortage in the United States. Pfizer is facing supply shortages for sterile injectable products mainly due to capacity constraints and technical issues.

To offset the threat of generic competition as well as other headwinds, Pfizer is strengthening its pipeline as well as oncology portfolio.

Pfizer boasts a strong pipeline and looks well positioned to deliver several potential new breakthrough innovative medicines in the next five years, which can drive long-term growth. Pfizer expects approximately 25 to 30 drug approvals through 2022, including around 15 products that have blockbuster potential. These also include line-extensions for Xtandi, Ibrance & Xeljanz/XR. Half of these potential blockbusters are expected to receive approval by 2020.

In oncology, Pfizer gained FDA approval for four innovative medicines in the last four months of 2018, which can boost its oncology sales. These include Daurismo (glasdegib) for previously untreated AML, Lorbrena (lorlatinib) for second-line non-small-cell lung cancer, Vizimpro (dacomitinib) for advanced NSCLC with EGFR activating mutations and Talzenna (talazoparib), an orally-available PARP inhibitor for advanced breast cancer.

A key candidate in the oncology pipeline is Bavencio (avelumab), which is being evaluated for different types of cancer. Bavencio is already approved in metastatic Merkel cell carcinoma in the United States, Europe and Japan. It has also received accelerated approval for second-line treatment of locally advanced or metastatic urothelial carcinoma in the United States. Bavencio, though approved for two small indications currently, is being considered a key long-term growth driver for Pfizer if it can gain label expansion approvals.

Biosimilars are also expected to contribute to growth in 2019. Pfizer launched Inflectra, its first biosimilar version of Merck/J&J’s Remicade in November 2016. Gradually, Pfizer is venturing into the oncology biosimilars space. In Europe and United States, it markets biosimilar versions of Amgen’s AMGN drugs Neupogen and Epogen. Biosimilar version of Roche’s RHHBY cancer drugs Herceptin (trade name: Trazimera) was approved by the FDA in March. Biosimilar versions of Roche’s other cancer drugs Rituxan and Avastin (trade name: Zirabev) are also under review in the United States with FDA decisions on all expected in 2019.

With a biosimilar version of AbbVie’s ABBV Humira also under review in the United States, Pfizer expects potential U.S. approvals for up to four biosimilar products in 2019. Biosimilar versions of Herceptin and Avastin are already approved in the EU while that of Rituxan is under review in the EU. Pfizer is evaluating several biosimilar molecules in various stages of development.

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