--- title: News on Approval of the First Interchangeable Biosimilar Insulin and More description: Elixir monitors the drug pipeline, evaluating changes and informing our clients of drug approvals, generic launches, new indications and developments. image: https://blog.elixirsolutions.com/hubfs/Blog%20Images/Oct-PoP-2.jpg --- [![Elixir_Logo_Tag](https://visiblydifferent.envisionrx.com/hubfs/Elixir_Logo_Tag.png "Elixir_Logo_Tag")](http://www.elixirsolutions.com) [![](https://blog.elixirsolutions.com/hubfs/Blog%20Images/Oct-PoP-2.jpg) ](https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021) # News on Approval of the First Interchangeable Biosimilar Insulin and More From development of a medication for treatment-resistant HIV with a novel mechanism of action to approval of Pfizer's COVID-19 vaccine, learn about the most impactful changes at each stage of the drug pipeline in this edition of Perspective on the Rx Pipeline. # Perspective on the Rx Pipeline ## Clinical Pipeline Within the extensive pipeline of drugs preparing for market launch, these are the three most notable drugs plan sponsors should be aware of: - **GS-6207**, a medication for treatment-resistant HIV-1 patients with a novel mechanism of action that interrupts several stages of the viral lifecycle, potentially keeping the virus from becoming infectious and invading uninfected cells.   - **TEZSPIRE™,** a biologic for the treatment of asthma with a new mechanism of action that may impact a broad population of severe asthma patients.  - **MK-7264**, if granted FDA approval, would be the first treatment specifically for refractory chronic cough, which is currently often treated with off-label products.       ## Drug Approvals Seven drugs recently approved by the FDA include: - **Bylvay™ (odevixibat)**, the first FDA-approved treatment for pruritus (itching) due to progressive familial intrahepatic cholestasis.   - **Comirnaty®** **(COVID-19 vaccine mRNA)**, previously granted emergency use authorization status, this first-of-its-kind mRNA vaccination for COVID-19 has been granted full FDA approval for those 16 years of age and older. - **Kerendia® (finerenone)**, approved to reduce the risk of complications in patients with chronic kidney disease and type 2 diabetes. - **Korsuva™ (difelikefalin)** has been approved as a treatment of pruritus for those with chronic kidney disease undergoing hemodialysis. - **Rezurock™ (belumosudil)**, a new pharmacological option for refractory graft-vs-host disease, a common complication of allogenic hematopoietic cell transplants. - **Saphnelo™ (anifrolumab)**, the first drug for the treatment of systemic lupus erythematosus in over 10 years, offering a new mechanism of action. - **Semglee® (insulin glargine-yfgn)** is the first FDA-approved biosimilar insulin that is interchangeable, or can be substituted for Lantus®. ## New Indications Drugs that have gained FDA approval for the treatment of additional diseases and/or conditions and have potential to be impactful include: - **Brukinsa®** **(zanubrutinib)**, approved to treat Waldenström's macroglobulinemia, it received the additional indication to treat patients with relapsed or refractory marginal zone lymphoma. - **Invega Hafyera™** **(paliperidone)** is a twice-yearly injectable antipsychotic for schizophrenia. - **Jardiance® (empagliflozin)** was expanded to reduce the risk of cardiovascular disease death plus hospitalizations in patients with heart failure. - **Pradaxa® and Pradaxa® pellets (dabigatran etexilate) **was approved for pediatric indications related to venous thromboembolic events (VTE) and for reducing the risk of VTE recurrence, making it the first oral blood thinning medication approved for children. - **Xarelto® (rivaroxaban),** approved for the indication to reduce the risk of major thrombotic vascular events in patients with peripheral artery disease. - **Xywav® (calcium oxybate; magnesium oxybate; posassium oxybate; sodium oxybate)** received the additional indication to treat idiopathic hypersomnia. ## Generic Approvals There are several new generic product offerings to the marketplace, including drugs for the treatment of hypertension, arthritis and multiple sclerosis. A review of generic launches, including biosimilars, is provided in the full report. **[Download the full report](https://blog.elixirsolutions.com/hubfs/Documents/clin_dm-pipeline_ext_article_oct%20highlights%20pop_21-6642_vpf4.pdf) for more information, including important safety updates and drug shortages and discontinuations.** Topics: [Perspective on the Rx Pipeline](https://blog.elixirsolutions.com/tag/perspective-on-the-rx-pipeline) [![Share on facebook](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/facebook-color.png?width=24&name=facebook-color.png) ](http://www.facebook.com/share.php?u=https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021&utm_medium=social&utm_source=facebook) [![Share on linkedin](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/linkedin-color.png?width=24&name=linkedin-color.png) ](http://www.linkedin.com/shareArticle?mini=true&url=https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021&utm_medium=social&utm_source=linkedin) [![Share on twitter](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/twitter-color.png?width=24&name=twitter-color.png) ](https://twitter.com/intent/tweet?original_referer=https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021&utm_medium=social&utm_source=twitter&url=https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021&utm_medium=social&utm_source=twitter&source=tweetbutton&text=) [![Share on email](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/email-color.png?width=24&name=email-color.png) ](mailto:?subject=Check%20out%20https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021&utm_medium=social&utm_source=email%20&body=Check%20out%20https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021&utm_medium=social&utm_source=email) ![Share on print](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/print-color.png?width=24&name=print-color.png) ### Post By Topic - [Clinical Trends & Insights (17)](https://blog.elixirsolutions.com/tag/clinical-trends-insights) - [Getting to know Elixir (7)](https://blog.elixirsolutions.com/tag/getting-to-know-elixir) - [Industry Updates (20)](https://blog.elixirsolutions.com/tag/industry-updates) - [Perspective on the Rx Pipeline (13)](https://blog.elixirsolutions.com/tag/perspective-on-the-rx-pipeline) - [Solutions & Best Practices (22)](https://blog.elixirsolutions.com/tag/solutions-best-practices) - [Trends & Insights (3)](https://blog.elixirsolutions.com/tag/trends-insights) [See all](https://blog.elixirsolutions.com/perspective-on-the-rx-pipeline-oct-2021#) ### Receive Insights in your Inbox [![Highlights Download CTA_graphic v2](https://blog.elixirsolutions.com/hs-fs/hubfs/Blog%20Images/Highlights%20Download%20CTA_graphic%20v2.jpg?width=1200&name=Highlights%20Download%20CTA_graphic%20v2.jpg)](https://blog.elixirsolutions.com/hubfs/Documents/clin_dm-pipeline_ext_article_oct%20highlights%20pop_21-6642_vpf4.pdf)   [elixirsolutions.com](https://www.elixirsolutions.com/) [![Share on linkedin](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/linkedin-color.png?width=24&name=linkedin-color.png) ](https://www.linkedin.com/company/elixir-craftedrxsolutions/) [![Share on twitter](https://blog.elixirsolutions.com/hs-fs/hubfs/Root/Social%20Icons/twitter-color.png?width=24&name=twitter-color.png) ](https://twitter.com/ElixirPBM) ## [TERMS OF USE](https://www.elixirsolutions.com/home/terms-of-use)          [PRIVACY POLICY ](https://www.elixirsolutions.com/home/privacy-policy)         [PRIVACY NOTICE](https://www.elixirsolutions.com/home/privacy-notice)         [ NON-DISCRIMINATION POLICY](https://www.elixirsolutions.com/home/non-discrimination-policy) ## © 2026 Elixir All rights reserved