Qilu, Kelun, Fuhong Henlius and other intensive layout!

On September 8, CDE issued a notice on the public solicitation of "Guidelines for the Design of Clinical Trials of Cetuximab Injection Biosimilar Drugs (Draft for Solicitation of Comments)"

The global patent of cetuximab has expired in 2017.

Local pharmaceutical companies compete for layout

Has reached clinical stage III at the fastest

According to incomplete statistics from reporters of the "Pharmaceutical Economics Daily", as of now, more than 10 local companies have deployed cetuximab biosimilar drugs, but no company has submitted a listing application for the time being

According to the newly disclosed semi-annual report, Kelun Pharmaceuticals stated that the phase III head-to-head study of A140 compared to the original cetuximab was completed last year before the start-up.

  According to Frost & Sullivan’s statistics and predictions, the colorectal cancer and nasopharyngeal cancer market sales of EGFR monoclonal antibodies in China in 2018 will be 1.
28 billion yuan, and in 2023 and 2030, the market sales of colorectal cancer and nasopharyngeal cancer will be The amount will increase to 3.
85 billion yuan and 6.
62 billion yuan respectively
.
If EGFR monoclonal antibody can be approved for indications for other tumor types in the future, its market size is expected to further expand
.
Under the new guiding principles of clinical trial design, which local pharmaceutical company will take the lead in crossing the line, waiting to see
.

In the context of centralized procurement

Accelerated development of biosimilars

  In the context of the industry in which the consistency evaluation of generic chemical drugs has entered the zone, the promotion of the development of biosimilar drugs has also been put on the agenda
.
In February of this year, CDE issued the "Technical Guidelines for the Evaluation of the Similarity of Biosimilars and the Extrapolation of Indications".
Based on the previous "Technical Guidelines for the Development and Evaluation of Biosimilars (Trial)", the CDE further supplemented the similarities of biosimilars.
Guiding suggestions for the extrapolation of evaluation and indications, to further standardize and guide the development and evaluation of biosimilar drugs
.
  

  At the same time, CDE has successively issued clinical guidelines for biosimilars of single species such as liraglutide, trastuzumab, rituximab, adalimumab and bevacizumab, and has a great The kinetics, effectiveness comparison study, safety and immunogenicity study and other evaluation indicators of the clinical experimental design and end points are explained, and the main research end points are recommended for each drug
.
This time, for cetuximab injection biosimilar drugs, CDE also takes into account the characteristics of this variety, and puts forward many suggestions for pharmaceutical companies to carry out clinical comparison studies in a targeted manner
.
  

  According to relevant statistics, as of the end of 2020, about 270 biosimilar drugs in China are in the state of research and development, more than half of which are still in the preclinical research stage, and 65 drugs have submitted clinical trial applications
.
Currently, blockbuster biologic drugs including rituximab, adalimumab, bevacizumab, trastuzumab, and infliximab have been approved for the marketing of biosimilar drugs, and competition for some varieties has become a red sea.

.
Insiders pointed out that the series of single-variety guiding principles issued by CDE will to a large extent prevent pharmaceutical companies from getting together in the field of biosimilar drugs and have the same layout, and will effectively reduce repeated investment in construction
.
  

Domestic approved monoclonal antibody biosimilar drugs and their original research products