Biyobenzerlerin geliştirilmesi teknik olarak, jenerik ilaçların geliştirilmesinden daha zorlayıcıdır, çünkü eski ilaçlar hastalarda klinik çalışmaları gerektirir ve referans ilaçları kalite, güvenlik ve etkinlik açısından eşleştirmek üzere tasarlanmıştır. Ürünün karmaşık yapısı nedeniyle, biyobenzerlerin gelişimi ve düzenleyici yolu, jenerik ilaçlardan önemli derecede farklıdır. Ve ilerleme raporu:
The biosimilar space was in focus in 2017 on key FDA approvals.
Biosimilars contain a version of the active substance of an already approved original biological drug. Development of biosimilars is technically more challenging than the development of generic drugs as the former requires clinical studies in patients and are engineered to match the reference drug in quality, safety and efficacy. Due to the complex nature of the product, the development and the regulatory pathway of biosimilars differ significantly from that of generics. A biosimilar is usually less expensive than the branded drug. Thus, the market for the same is highly lucrative. With the acceleration in approvals of biosimilars, the market has thus attracted a lot many players which are witnessing rapid growth. Here we go through the progress report for 2017.
Merck & Co., Inc . MRK launched Reneflexis, a biosimilar version of Remicade (infliximab), in the United States in July 2017 after approval in April. The FDA also granted tentative approval for Lusduna Nexvue, the biosimilar version of Lantus, basal insulin in a pre-filled dosing device. Merck currently carries a Zacks Rank #3 (Hold). You can see the complete list of today’s Zacks #1 Rank (Strong Buy) stocks here.
Remicade has been seeing intense competition in the biosimilars space of late. We note that Pfizer, Inc . PFE supplies Inflectra, a biosimilar version of Remicade. Pfizer is a strong player in the biosimilars market. In December 2017, Pfizer got FDA approval for another of its Remicade’s biosimilar, Ixifi, as a treatment for rheumatoid arthritis, Crohn’s disease, pediatric Crohn’s disease, ulcerative colitis, ankylosing spondylitis, psoriatic arthritis and plaque psoriasis. The company has a portfolio of three marketed biosimilar medicines outside the United States, including Inflectra, Retacrit (epoetin zeta) and Nivestim (filgrastim) along with a strong pipeline of 13 distinct biosimilar molecules in various stages of development. Pfizer currently carries a Zacks Rank #3.
Generic leader Mylan NVMYL is also exploring the biosimilars market – that has the potential to grow to $20 billion by 2020. Early last December, Mylan and partner Biocon Ltd. announced the FDA approval of Ogivri (trastuzumab-dkst), a biosimilar version of Herceptin (trastuzumab). Ogivri has been approved for all indications included in the label of the reference product, Herceptin, including the treatment of HER2-overexpressing breast cancer and metastatic stomach cancer. Ogivri is the first FDA-approved biosimilar of Herceptin and the first biosimilar from Mylan and Biocon’s joint portfolio. Mylan currently carries a Zacks Rank #3.
Meanwhile, Amgen Inc . AMGN and Allergan plc . AGN won FDA approval for the biosimilar version of Avastin in September 2017 for the treatment of multiple types of cancer. We note that Mvasi is the first biosimilar approved in the United States for the treatment of cancer. Amgen’s biosimilar version of Humir, Amjevita, is already approved by the FDA and will be launched in the United States on Jan 31, 2023, after the company resolved litigation with the AbbVie, Inc. ABBV The companies have also submitted a BLA to the FDA for ABP 980, a biosimilar candidate to Herceptin in July 2017. We note that the companies are collaborating on four oncology biosimilars, including ABP 980, which is the second to be submitted for FDA approval. The companies also submitted a Marketing Authorization Application to the European Medicines Agency for the candidate in 2017. We note that Amgen has a total of 10 biosimilars in its pipeline, two of which have been approved by the FDA. Amgen currently carries a Zacks Rank #3.
Boehringer Ingelheim’s Cyltezo (adalimumab-adbm), another biosimilar of Humira, was also approved by the FDA in August 2017.
Medical – Generic Drugs Industry 5YR % Return
Owing to the slew of FDA approvals, we expect investors to remain focused on this space in the near future.
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