The original drug Skin-cap or an analogue: what are their differences?

Compound

Is it possible to replace the original drug Skin-cap with an analogue?

In theory, generics are developed precisely to provide consumers with as much choice as possible. Due to the relative cheapness of such products, ordinary people often prefer generics to original drugs. On the one hand, “substitutes” also provide a certain effect in the treatment of diseases. But at the same time, even a doctor cannot always predict the effectiveness of an analogue in comparison with the original drug.

Taking all this into account, it is necessary to clearly understand that the prescription of any treatment, including the use of generics, lies solely within the competence of the doctor.

But often a doctor finds himself in a situation where, having prescribed the original drug Skin-Cap to a patient, his recommendations at the pharmacy are replaced by a pharmacist, offering a cheaper drug (analog) or a cosmetic care product with zinc pyrithione, which cannot have a therapeutic effect. The patient was treated, but did not get the desired effect and returns to the doctor with a complaint. That is why doctors often recommend a specific trade name when prescribing an original drug.

Pharmacodynamics

Activated zinc pyrithione has anti-inflammatory, antibacterial and antifungal activity. Antifungal activity is especially pronounced against Pityrosporum ovale and Pityrosporum orbiculare, which support inflammation and excessive flaking in dandruff, seborrhea, psoriasis and other skin diseases.

The antibacterial activity of zinc pyrithione is manifested against a number of pathogenic microorganisms (including streptococcus, staphylococcus, Pseudomonas aeruginosa and Escherichia coli, Proteus).

Zinc pyrithione reduces the intracellular level of ATP, promotes depolarization of cell membranes and the death of fungi and bacteria.

The mechanism of anti-inflammatory action has not been studied.

The production of original medicines is a constant investment

The work scenario of a pharmaceutical company that develops and produces original drugs is quite classic. The company is conducting a series of developments, testing various combinations of components, and synthesizing certain substances that help solve certain health problems. When the drug has been studied from all sides, it will be put into mass production and sales through pharmacies and pharmacy chains.

At first glance, the described process is very simple. But in reality everything is more complicated. To bring a new drug or active substance to market, it can take years or even decades for a pharmaceutical company. The development of new medicines involves a whole series of tests and trials. And you need to be prepared for the fact that some of them will lead to zero or negative results, then all processes will need to be started again. In general, the development, research, organization and conduct of clinical trials, as well as the resolution of related issues (licensing, certification, etc.) require the manufacturer not only years of work, but also impressive sums.

If we consider the original drug Skin-cap and its analogues, then when the drug Skin-cap was first released onto the market, the following steps were followed:

• Laboratory research. At this stage, the active substance has been tested in laboratory conditions. The research department studied the mechanisms and features of pathological processes in the skin in psoriasis, atypical and seborrheic dermatitis, and identified possible points of application of the drug. Based on the data obtained, experts selected an active substance that, theoretically and practically, can have a clinical effect.
• Preclinical trials. In this case, we are talking about the fact that the selected active substance was first studied using a laboratory model, which helps to determine the mechanisms of action of the active substance on the pathological process.
• Clinical trials are studies on volunteers that allow us to prove the effectiveness and safety of zinc pyrithione activated as part of Skin-cap in various groups of patients. All this makes it possible to determine the optimal dosage of the drug and identify the most common side effects.

But even after the release of the original drug Skin-cap on the market, the manufacturing company continues to confirm the effectiveness and safety of the drug by conducting studies in real clinical practice on large groups of patients. The most powerful studies are those with placebo control. Unlike analogs, the drug Skin-cap has such studies, and the total evidence base of the drug is about 50 studies that were conducted in leading clinical centers in Russia for various skin diseases. Thanks to such a strong evidence base, Skin-cap is included in current clinical recommendations for the treatment of psoriasis, atopic and seborrheic dermatitis.

Directions for use and doses

Externally.

Aerosol: spray onto the affected areas of the skin from a distance of 15 cm 2-3 times a day until a clinical effect is achieved. To achieve a lasting effect, it is recommended to continue using the drug for 1 week after the symptoms disappear. To treat the scalp with the drug, a special nozzle is included. The course of treatment for psoriasis is 1-1.5 months, for atopic dermatitis - 3-4 weeks.

The method of administration and dosage for children do not differ from those for adults.

If necessary, you can repeat the course of treatment after 1–1.5 months, after consultation with your doctor.

Cream: after vigorous shaking, apply a thin layer to the affected areas of the skin 2 times a day. The course of treatment for psoriasis is 1-1.5 months, for atopic dermatitis - 3-4 weeks.

The method of administration and dosage for children do not differ from those for adults.

If necessary, you can repeat the course of treatment after 1–1.5 months, after consultation with your doctor.

Shampoo: before use, shake the bottle vigorously, apply a small amount of shampoo to damp hair and massage the scalp, then rinse your hair and reapply shampoo. Leave the shampoo on your hair for 5 minutes and rinse thoroughly with plenty of water. Use 2-3 times a week for the first 2 weeks. The course of treatment for psoriasis is 5 weeks, for seborrhea - 2 weeks.

During the period of remission, shampoo can be used 1-2 times a week as a means of preventing relapses.

Why are analogues and original drugs not the same thing?

Patients often hear from a dermatologist that the clinical results from using the drug Skin-cap and its analogue are different.

You should not assume that the original drug Skin-cap and its analogues are equivalent in effectiveness.

In fact, manufacturers of analogues are required to use the same active substance in their products as in the original drug. Generics themselves must meet several criteria:

• produced in the same form as the original (that is, it can be a cream, aerosol, shampoo);
• have a similar pharmacological effect, that is, the ability to be used to treat the same diseases.

Thus, the instructions for the original drug Skin-cap and its analogue will be practically indistinguishable.

The analogue, like the original drug Skin-cap, also undergoes certain tests. However, we are not talking about conducting full-fledged preclinical and clinical trials in the usual sense. The task is to prove the comparability with the original molecule and the safety of your product.

As for clinical studies, analogues of the drug Skin-cap often use the results obtained in studies using the original drug, and, as a rule, have only 1-2 of their own studies, which are often conducted without placebo control.

Due to all these factors, the production of generics is significantly reduced in cost. However, it is incorrect to talk about their complete equivalence with original drugs.

If you are trying to figure out how a generic drug differs from an original drug, you should not forget about such a thing as production standards. Different countries set their own quality criteria for the production of “substitutes” for medicines.

In order to minimize costs, analogue manufacturing companies often choose cheaper production lines, but at the same time invest in advertising promotion. The original Skin-cap is produced in Europe (Spain/France) in accordance with national and international quality standards.

Release form

Aerosol for external use, 0.2%. 35, 70, 140 g of the drug in an aluminum aerosol can, which consists of a valve and a cap. The cylinder along with an additional nozzle is placed in a cardboard box.

35 g of the drug in an aluminum aerosol can, which consists of a valve and a cap (free sample).

Cream for external use, 0.2%. 5 g in a sachet made of laminated foil. 15 and 50 g in a plastic tube. Each tube is placed in a cardboard box

Shampoo, 1%. 50 ml, 150 ml, 400 ml in a plastic bottle. Each bottle is placed in a cardboard pack. 5 g in a sachet made of laminated foil. 5 sachets are placed together in a cardboard pack. 5 g in laminated foil sachets (free sample).

Why are generics so much inferior to original drugs?

There are several objective reasons why the analogues and the original drug Skin-cap cannot be considered completely identical. The main difference comes down not only to the difference in the auxiliary components in the “substitutes”. There are other, no less significant factors.

Feedstock for production

The requirement to use a similar active substance in generics is strictly fulfilled by manufacturers. However, they select suppliers at their own discretion and use other methods of obtaining raw materials. Differences in technology can produce completely different end results. The main danger lies in the fact that generics often use raw materials with a low degree of purification.

List of auxiliary components

It may seem that the presence of additional components in generics does not play any role. Manufacturers often insist that by adding new ingredients (for example, panthenol), the formula becomes even more effective, safer, better quality, etc. In fact, this is nothing more than a classic marketing ploy.

Adding auxiliary components, at best, does not carry any meaning, since in most situations the additives used are either not perceived by the body or do not have the desired effect due to their low concentration. And in the worst case, it can affect the effect of the active substance by changing its interaction with the skin.

How to distinguish an original drug from a generic?

There are several key aspects that can help you figure out which drug is in front of you.

1. Duration of circulation of the drug on the market. The original drug Skin-cap has been circulating on the Russian market for more than 25 years, but analogues come out much later (after 10-15 years).
2. Price. The price of a medicine is a fundamental factor by which one can distinguish the original sample from the “substitute”. Because production costs for generic drugs are significantly reduced, they usually cost less at retail. Sometimes the price difference is three to four times.
3. Package. The manufacturer of the original drug Skin-cap has invested a lot of money in the development of packaging. It is well recognizable and made of high quality material. For example, the ergonomic packaging of Skin-cap cream ensures economical consumption due to its narrow neck, the cream closes “up to the cheek”, and the lid itself is non-removable, which protects the drug from accidental consumption and contamination.