FALSE. An originator drug is a drug that is discovered, developed and marketed by a pharmaceutical or biotechnology company, and this, after having been patented, that is to say protected from any imitation or reproduction for a good period of time, approximately 20 years…

When the patent of the original drug (originator) with a small molecule expires, other companies can manufacture and sell identical copies of this drug, which are called generic. Their active ingredients are of chemical origin and they are identical, they act in the same way. Their production is profitable. Unfortunately, the latter have therapeutic limits with regard to certain serious pathologies.

Biological drugs are thus revolutionizing the management of these pathologies including certain chronic diseases. These are drugs that are produced using modern biotechnology, proteins from living organisms, manufactured by living cells.

In the case of biological drugs, we no longer speak of generics but of biosimilar drugs. A similar biotherapeutic product (also called a biosimilar) is a biotherapeutic product that is similar in quality, safety, and efficacy to a previously approved reference product and that does not have any clinically significant differences from a reference product approved by the FDA. (Food and Drug Administration).

The development of biosimilars requires significant technical expertise and advanced technology.

TRUE. The development of biosimilars is longer (7 to 8 years) and more expensive. Their approval requires the demonstration of efficacy and safety comparable to the reference biological medicine; this is not required for generics. The latter have a lower cost and development time.

IS THE MONITORING OF A BIOSIMILAR IDENTICAL TO THAT OF THE REFERENCE BIOLOGICAL DRUG?

IS A BIOSIMILAR MORE EFFECTIVE THAN THE REFERENCE BIOLOGICAL DRUG?

TRUE. The biosimilar has comparable safety and efficacy to its reference biological medicine.

ARE BIOSIMILARS RECENT DRUGS?

TRUE. These provide:

A significant price reduction compared to reference drugs, thus contributing to a rationalization and a reduction in the economic bill of the health system

They also allow for wider availability and access for patients to these treatments.

Better balance and sustainability of the national economy via technology transfer allowing the optimization of national production and job creation

Finally, they contribute to the dynamics of medical innovation by stimulating competition.

IS INTERCHANGEABILITY POSSIBLE FOR BIOSIMILAR DRUGS?

FALSE

Interchangeability:

Interchangeability is a medical act that consists, at the initiative of the prescriber, in replacing a biological drug with another similar one.

It can take place at any time during treatment.

It must be reasoned and take into account the patient’s interest. The following three conditions must be respected:

Inform the patient and obtain their agreement;
Ensure appropriate clinical monitoring during treatment;
Ensure traceability of the products concerned (the prescribed product must be recorded in the patient’s file). ANSM 2022

Switching:

Decision by the treating physician to exchange a medicine for another medicine with the same therapeutic intention in patients already under treatment. As a general rule, generic medicines can be dispensed in place of prescribed reference products without the consent or knowledge of the prescribing physician.

Substitution:

Substitution is the switch from one specialty on medical prescription to another specialty, decided by the pharmacist, without consultation with the prescribing physician.

TRUE

Biosimilar drugs can be used in the therapeutic protocol of certain chronic diseases, such as rheumatological, hepatic, diabetology and cancer diseases.

Biosimilars can be used in the Covid-19 protocol also due to the various clinical manifestations that can occur long after recovery and that can lead in the long term to the appearance of chronic diseases.

TRUE

We are among the laboratories producing biosimilars in Algeria, we have all the biotechnological arsenal necessary to cover the entire process essential to the production of biosimilars.

We invite you to consult our page « Biosimilar drugs » for more information.

Link to the biosimilar drug page: https://en.frater-razes.com/nos-medicaments-biosimilaires

You can reach us on our website, by phone or via our various social networks.

Contact page link: https://en.frater-razes.com/contact

Digital channels link: https://linktr.ee/fraterrazes

Our headquarters is located at this address: 08 site oued el kerma -saoula Algiers.

The Google map and all the information are available on our « Contact » page, please consult it:

Contact page link: https://en.frater-razes.com/contact

We are available from Sunday to Thursday from 8 a.m. to 5 p.m.

Our strategic areas of activity are diverse and varied, ranging from production, distribution to export.

We have a wide range of pharmaceutical products ranging from generic to biosimilar, intended for pharmacies and hospitals, but also food supplements.

We invite you to consult our « Activities/Subsidiaries » and « Products » pages for more information.

Link to the Activities & Subsidiaries page: https://en.frater-razes.com/la-distribution-somepharm
Link to our Products page: https://en.frater-razes.com/tout-les-medicaments

The FRATER-RAZES pharmacovigilance department aims to promote the rational use of our medicines; to propose measures to reduce the risks and severity of adverse effects linked to the use of all FRATER-RAZES products; and to improve information on risk and its prevention; in order to guarantee the safety of our patients.

De ce fait, merci de consulter la page « pharmacovigilance » pour déclarer tout effet indésirable.

Lien page Pharmacovigilance : https://en.frater-razes.com/contact-pharmacovigilance/ 

Export represents a key strategic area of ​​activity for our group, which has been conquering international markets since 2019.

For more information about export, please visit our page « Export and international development »

Link to the Export and international development page: https://en.frater-razes.com/export-et-developpement-a-linternational