News

Biologically Similar Medicine

  • Author:Jane
  • Source:ZHIYAO
  • Release on :2017-08-31
On Friday, the US Food and Drug Administration announced that the German drug company Boehringer Ingelheim's Adalmu monoclonal antibody Cyltezo was approved as the newly approved bio-similar drug of Albert's maintenance.

However, the listing of this new drug may not be as fast as imagined. In September last year, the FDA approved the biology similar drugs, Amjevita, but has not yet been listed.

Analysts believe that Albergo in a few years also sit quiet beauty music, will not see the competition of biological similar drugs.

This is because, biological similar drug patent disputes, jargon, "biological similar drug patent dance."

The so-called patent dance (Patent Dance), refers to the biological drug manufacturers and generics companies must communicate, before the listing of biosimilars to clarify the original drug and generic drug patent disputes.

The original factory manufacturers of patent litigation, often hinder the listing of biological similar drugs.

FDA approved the first bio-similar drug, is Novartis's Shan Deshi company's non-grid Ting, said Amgen company Neupogen You Baojin biological similar drugs.

Despite the approval, but Sanders soon found that patented products so that products can not be listed. After several months of court debates, Sandoz even resorted to the Supreme Court.

Sandoz is not the first, it will not be the last one. Similar patent disputes are there, Yang Sen and Hao Shengrui / Celltrion company around Remicade, Canada Apotex and Anjin around Neulasta.

Compared with the United States of biological similar drugs "tear" compared to the EU market seems to be much more smooth.

In a recent report, Ronny Gal, a biotechnology analyst at stock market analysis firm Bernstein, said the EU's use of biosimilars "continues to be surprising."

Just last week, the EU Medicines approved the Samsung Bioepis Imraldi, which is a similar drug of Albert's maintenance of Merlot. This is also Samsung in the EU approved the third biological generic drugs.

Compared to the United States, this approval may be more favorable.

For example, Boehring's Cyltezo can not automatically replace with the original research (Non-Interchangeable).

Moreover, the EU's approval includes 28 countries. With the increase in the country, the EU may be more attractive to bio-similar drug manufacturers.

"The price is low (50% discount compared to the original research), the business model does not require a lot of marketing promotion requirements and support.In addition, the major markets (Enley Enbrel, Epogen and grams of Remicade) the number of late competitors Only 3-4, indicating that profitability will continue, "Galle wrote.

It may also explain that Biocon, India's largest biopharmaceutical company, has recently been anxious. The European Medicines Agency informs that Biocon's facilities for the production of Herceptin biocompatible drugs will be re-inspected. At the same time, the application documents will be withdrawn at the same time.

However, Gal is neutral against antitumor drugs. "The bigger test of the upcoming is anti-tumor products (Meiluohua Rituxan Biomedical Drugs listed and Herceptin's similar drugs are expected).

However, "Neulasta Biomimetic Drugs will be launched in 2018 and will do well in the EU market."

The US market is quite different, and he points out that "two key kernels": first, Epogen and Neulasta's approval was delayed for a year, and the approved class of Remicade's bio-similar drug "failed to gain market acceptance and was exposed The US market is encouraging some of the weaknesses of bio-similar drugs, "although he expects this to change in the coming year.

He also predicted that the third wave of biological similar drugs are coming. At least five projects will begin clinical trials, including the Tysabri (natalizumab) biosimilts of Bacchus Biogen for the treatment of multiple scleroderma, the Orencia (abatacept) of rheumatoid arthritis, the treatment of anemia in Aranesp (Darbepoetin alfa) and regenerated meta regeneron for Eylea (aflibercept), which treats wet macular degeneration, are "most likely."

http://raps.org/Regulatory-Focus/News/2017/08/28/28340/FDA-Approves-6th-Biosimilar-in-US-Second-for-Humira/