Biological drugs are drugs, the common feature of which is that their active substances are biological polymers or supramolecular aggregates (structures) produced by living organisms or living cell cultures. What are the types of biological drugs?

Biological drugscover the entire spectrum of active substances, from relatively simple substances such as growth hormone or insulin, through more complex ones, such as antibodies, to gene vectors or viruses. Recently, biological drugs even include cells administered for therapeutic purposes. What are thetypes of biological drugs ?

Biological drugs: types

  • biological drugs of natural origin - the active substances of which are obtained from non-genetically engineered living organisms (animals, plants or microbes) or from human blood, e.g. heparin (from pig intestinal mucus), streptokinase (from streptococcal bacteria) , bromelain (from pineapples), albumin (from plasma);
  • biological drugs obtained with the use of genetic engineering methods (in other words: biological drugs biotechnological) - these are drugs whose active substances are obtained with the help of cells or organisms into which foreign genes (transgenes) have been introduced; most often they are the so-called recombinant proteins, which in turn may be structurally similar to, or may be structurally different from, natural proteins (e.g., fusion proteins which are non-natural combinations of different protein fragments).

Biotechnological drugs: types

In turn, among biotechnological biological drugs we distinguish:

  • innovative biotechnological biological drugs - that have been registered (usually for the first time) on the basis of a complete registration dossier;
  • biotechnological biosimilar drugs - registered on the basis of the abridged registration dossier containing studies showing biological similarity of the drug to the innovative reference drug.

Biological drugs versus biotechnological biosimilar drugs

The term "biosimilar drugs" is a translation of the English term "biosimilar drugs", officially used in the European Union. In Poland, the adjective "biopodobny" is associated withwith the terms "chocolate-like", "cheese-like", etc. - that is, it is a cheaper product, but less valuable, substitute, surrogate. This unfortunate combination, completely misapplied to biosimilars, has given rise to further misunderstandings. One of the most harmful is comparing, and often even opposing, biosimilar drugs - biological drugs. These concepts cannot be compared, and even less opposed - because they refer to different levels of reality.

Biosimilars are not generics

In some respects, the term "biosimilars" resembles the term "generics" (or "generics") used for drugs containing low-molecular, chemically defined active substances. Both generics and biosimilars are drugs produced by alternative manufacturers after the expiry of the exclusive rights of patent protection by the manufacturer of the innovative drug. The difference is that in the case of low molecular weight substances (which are usually obtained by chemical syntheses), their chemical structure is clearly defined and at the same time unambiguously determines the pharmacological properties of the drug. Thus, once the identity of active substances has been demonstrated by physicochemical methods, clinical trials are no longer needed (only, for some oral formulations, comparative pharmacokinetic studies). That is why generics are much cheaper than the original drugs. However, in the case of biological drugs, the currently known physicochemical methods do not characterize active substances sufficiently to clearly define their pharmacological properties. Small, sometimes even imperceptible differences in the methods used today may significantly affect the safety and efficacy of the drug. Therefore, the EMA believes that the term "generic drug" or "generic" cannot be used for biological medicines.

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