Biologics are a valuable modern therapy option, especially when it comes to chronic inflammatory diseases such as rheumatoid arthritis, Crohn's disease and psoriasis, whereby they can reduce the inflammatory processes.
Biologics are biotechnologically manufactured active ingredients. This means they are not chemically manufactured, but rather produced in living cells as proteins similar to the body's own proteins. This means their manufacturing process is considerably more complicated than that of chemical drugs. When treating autoimmune diseases, they are often administered permanently, as they act directly in the immune system. In advanced cases of the disease, they have the advantage that they can often work more quickly and effectively than traditional chemical drugs.
So-called biosimilars are one type of biologic. They are biologics that are very similar to a previously authorised biologic, but have not undergone the same production/manufacturing process. Due to the complicated biotechnological manufacturing process, a biosimilar is only ever very similar to an original biologic; they are never completely identical.
One example of the use of biologics is the treatment of advanced chronic inflammatory diseases. These include rheumatic diseases such as rheumatoid arthritis, juvenile idiopathic arthritis, axial spondyloarthritis and psoriatic arthritis, as well as skin diseases such as acne inversa or psoriasis. Chronic inflammatory bowel diseases such as Crohn's disease and ulcerative colitis as well as non-infectious chronic inflammation of the eye (uveitis) also fall under this category.
As is also the case with other medication groups, biologics can act in a number of different ways. So-called monoclonal antibodies are a sub-group of biologics. They intervene in misdirected immune system processes by blocking pro-inflammatory messengers such as tumour necrosis factor-alpha, or TNF-ɑ for short. They include the active ingredients infliximab and adalimumab, for example.
When the immune system recognises an injury or the invasion of potentially dangerous substances, it sends out so-called messengers, e.g. TNF-ɑ, as a defence mechanism. This messenger ensures that inflammation occurs at the site in question: the blood vessels widen in order to accelerate the healing process through the increased blood supply and to flush out pathogens through the increased fluid flow. Pain signals are also triggered and they serve to protect the body, as they are telling those affected to take it easy in order to avoid further injury. In healthy people, inflammation therefore fulfils an important purpose. With chronic inflammatory diseases, however, the disadvantages of this defence mechanism outweigh any advantages - for various reasons, the immune system increasingly targets the body's own structures and the inflammatory processes no longer regulate themselves back down in the normal way.
In order to be authorised as a biosimilar, the active ingredient must be demonstrably comparable to the original biologic in terms of efficacy and safety. Compared to the authorisation of a new biologic, the authorisation of a biosimilar involves fewer studies than an original biologic. As a result, biosimilars are often less expensive than the original biologic. They can also offer additional benefits. For example, it is possible to imagine a change in the form of administration or the elimination of certain allergy-promoting ingredients. Celltrion Healthcare is continuously working on improving and developing its biosimilars further.
In order to be effective, biologics must enter the bloodstream. With most of the biologics currently available, the active ingredient is administered via an infusion or injected under the skin. As the complex protein compounds and nucleic acids of biologics would be destroyed when passing through the gastrointestinal tract, taking them in the form of tablets or drops is not possible.
If biologics are administered via a syringe or pen under the skin, i.e. as a subcutaneous injection, they can in most cases be administered by the patient in the comfort of their own home or by nursing staff after training using pre-filled syringes or pens.
Have you been prescribed a biosimilar from Celltrion Healthcare for your chronic inflammatory disease? More information on your medication and self-injection can be found after logging in here.