Benepali biosimilar gets positive opinion from CHMP

[Fred]

Following on from this report Enbrel biosimilar candidate, SB4 accepted for review by European Medicines Agency
Biogen announced it has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Benepali™ (etanercept). Previously known as SB4.

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Biogen announced further progress as part of its commitment to biosimilars. Samsung Bioepis, the joint venture between Samsung Biologics and Biogen, has received a positive opinion from the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) for the marketing authorization of Benepali™ (etanercept). Previously known as SB4, Benepali is a biosimilar candidate to the reference product Enbrel®1. The positive opinion will now be referred to the European Commission (EC), which grants marketing authorization for medicines in the European Union (EU). If approved, Benepali could be the first biosimilar of Enbrel granted approval in the EU, as well as the first subcutaneous anti-TNF biosimilar there.

“The positive CHMP recommendation for Benepali is a great step forward for patients, physicians and payers in Europe. Biosimilars have the potential to help improve access to important biologic treatments for those who need them most,” said Alpna Seth, vice president and global head of the biosimilars business unit at Biogen. “As a biotechnology leader with more than 35 years of experience in developing, manufacturing and commercializing advanced biologics, we look forward to bringing an array of anti-TNF biosimilar medicines to patients across Europe.”

The CHMP’s positive opinion was based on a robust preclinical and clinical data package submitted to the EMA by Samsung Bioepis. The data in the preclinical submission leveraged sophisticated molecular analytics, technical development, and manufacturing expertise, together with confirmatory data from head-to-head Phase 1 and Phase 3 clinical trials of Benepali compared to its reference product Enbrel 2,3. The 52-week, double-blind, Phase 3 study randomized 596 patients with moderate to severe rheumatoid arthritis (RA) despite methotrexate therapy across 70 sites in 10 countries to receive Benepali or Enbrel in a 1:1 ratio. Results showed an ACR20 response rate of 80.8% in the Benepali arm versus 81.5% in the Enbrel arm. The safety profile of Benepali was comparable to that of Enbrel.

Source: biogen.com

[Caroline]

Good that cheaper and still good medication is coming available.

Still. The size of the company begins to scare me. Remember, their goal is earning money for their stakeholders.

[Fred]

Good that cheaper and still good medication is coming available.

Still. The size of the company begins to scare me. Remember, their goal is earning money for their stakeholders.

Yes but every manufacturer of everything only does it for money. C'est la vie

[mataribot]

Let's cut the poop. Biosimilars are NOT similar or even a copy of the patent drug. They are just another TNF that didn't have to go through all the requirements the patent drug did.

[Caroline]

Let's cut the poop. Biosimilars are NOT similar or even a copy of the patent drug. They are just another TNF that didn't have to go through all the requirements the patent drug did.

I didn't get that ! I will dive into that one a little, want to know more of that.

[Fred]

Let's cut the poop. Biosimilars are NOT similar or even a copy of the patent drug. They are just another TNF that didn't have to go through all the requirements the patent drug did.

Sorry Matari but I disagree.

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A similar biological or 'biosimilar' medicine is a biological medicine that is similar to another biological medicine that has already been authorised for use.

Biosimilars can only be authorised for use once the period of data exclusivity on the original 'reference' biological medicine has expired. In general, this means that the biological reference medicine must have been authorised for at least 10 years before a similar biological medicine can be made available by another company.

Role of the European Medicines Agency:
The Agency is responsible for assessing applications from companies to market biological medicines for use in the European Union (EU), including biosimilar medicines.

Requirements for authorisation of biosimilar medicines:
For biosimilar medicines, the company needs to carry out studies to show that the medicine:
#1 Is similar to the reference medicine.
#2 Does not have any meaningful differences from the reference medicine in terms of quality, safety or efficacy.

As information on the reference medicine is already available, the amount of information on safety and efficacy needed to recommend a biosimilar for authorisation is usually less than the amount needed to authorise an original biological medicine.

As with all medicines, the Agency continues to monitor the safety of biosimilar medicines once they are on the market.

How are biosimilar medicines evaluated in the EU?
Because the reference medicine has been authorised in the EU for several years and its clinical benefit is established, some studies carried out with the reference medicine may not need to be reproduced. Since 2003, a new EU pathway for approving biosimilar medicines has been in place. The main part of the evaluation is a comparison of the biosimilar with its reference medicine to show that there are no significant differences between them.
The relevant regulatory authority applies stringent criteria in their evaluation of the studies comparing the quality, safety and effectiveness of the two medicines. The studies on quality include comprehensive comparisons of the structure and biological activity of their active substances, while the studies on safety and effectiveness should show that there are no significant differences in their benefits and risks, including the risk of immune reactions.
Biosimilar medicines are manufactured following the same standards as for other medicines, and regulatory authorities perform periodic inspections of the manufacturing sites.

How is the safety of biosimilar medicines monitored?
As for all medicines, the safety of biosimilar medicines is continuously monitored after authorisation. Each company is required to set up a system to monitor side effects reported with its medicines. Patients can also report suspected side effects themselves. The regulatory authorities evaluate the safety data that is captured as well as the company’s safety monitoring system. When signals of a safety concern arise, regulatory authorities investigate and take action as appropriate.

Source: European Medicines Agency

Yes the original would have gone through more, but that is because it would have been a completely new drug and had to go through more rigorous testing. A Similar however is just a copy of the original and the testing isn't so costly to the manufacturer as most of the information on the product is out there and it has been used for ten years.