Biological medicines are derived or produced from living cells. The medicines are proteins, such as hormones or antibodies that the human body also produces. In certain diseases, their production shuts down or weakens so that the patient would die without the compensatory biological medicine.
The most important biological medicines are used to treat
- diabetes by substituting for the body’s own insulin production
- various cancers
- difficult skin and joint diseases
- inflammatory bowel diseases (IBD).
These medicines are normally administered as infusions or injections so that they remain effective and efficient.
Pharmaceutical development relieves burden in healthcare
Biological pharmacotherapies have been on the market for three decades while vaccines have a longer track record. There are about 300 biological medicines that have already been used to treat 350 million people globally. About 900 novel biological medicines are under development.
Owing to pharmaceutical development it has been possible to lighten the healthcare structures. Wards and even entire hospitals have been replaced by treatments given in outpatient care. At best, the patient can inject the biological medicine under their own skin at home.
The administration of biomedicines is also undergoing development to simplify the methods. It is a major aim for pharmaceutical industry to be able to crystallise the large-molecule biological pharmaceutical substances, turning the injectable solutions into tablets that are administered orally. This would further help to transfer the treatment from hospital to home.
Biological medicines save society's money
One in three medicines currently in development is a biological medicine. The cost of manufacture of biological medicines is manifold compared with conventional chemical medicines.
Biological medicines might seem expensive if we only look at the price. However, the medicine is inexpensive and efficient if all the societal impacts are taken into the calculations.
Through biological pharmacotherapies
- the patients gain additional working years
- the invalidity pension and sick leave costs are reduced
- therapies work faster which means less hospital bed needs
The use of biological medicines must be seen from the cost-effectiveness perspective.
Biosimilars are similar medicines
The patents of the oldest biological medicines have already expired. It is now possible for companies other than the original developers to manufacture them. The products that are similar to the original biological medicines are called biosimilars.
Biosimilars are not generic versions of the biological medicines. The biological medicine and its biosimilar are not identical or biologically equivalent in the same manner as the conventional chemical original medicines and their generics are. Therefore, the products are not automatically mutually substitutable by the pharmacy as is the case with certain chemical products.
Patient safety guaranteed by rigid quality control and watertight reporting on reactions
Ensuring the safety and therapeutic efficacy of biological medicines calls for relentless control. These medicines easily deteriorate, not only in manufacture but also during use. Compared with chemical medicines, it is also typical of biological medicines that they are associated with a higher risk of antibody formation.
It is vital that both the adverse reactions and safety of biological medicines are closely followed in patient use. It is more difficult to predict the individual effects of biological medicines than is the case with conventional products. The importance of follow-up also applies to biosimilars.
The exact product used by the patient must always be known and traceable, in order to be able to associate the eventual adverse reactions with the correct product, even at manufacture batch level. Consequently, biological medicines and respective biosimilars must always be prescribed and dispensed by their trade name, both in hospitals and in outpatient care.
Doctor decides on therapy in collaboration with patient
Due to the properties of biological medicines it is important that
- that the attending doctor chooses the product to be used in collaboration with the patient, irrespective of whether the medication takes place in inpatient or outpatient care.
- the selected product is not changed in the middle of the treatment without consulting the attending doctor who should take the decision
- the product remains the same when the patient moves from hospital to outpatient care
Moreover, the patient's own experience the dosage devise or similar factors is essential for adherence to treatment and success of the therapy.
Future use impacted by price competition
The importance of biological medicines is constantly growing. However, the relatively higher pharmaceutical expenses associated with biological medicines have limited their use in hospitals, also impacting their reimbursement status.
The biosimilars introduced to the market after the expiry of the patent of the original biological medicine will launch a price competition that brings therapy costs down. This may increase the opportunities to introduce novel medicines in hospitals, thereby contributing to their entry into the reimbursement system.