Abstract
The foundation of Homeopathic Medicine is the ‘Similia Principle’, also known as the ‘Principle of Similarity’ or also as the ‘Simile’, which reflects the inversion of pharmacological effects in healthy subjects as compared with sick ones. Individuality is the core concept for selection of medicine in Homoeopathy where it provides a process for identifying an individual to be most similimum with medicine. This process of Individualization is followed in the context of law of similia. Every aspect of understanding about the practice of homoeopathy follows the fundamental law of similia. Bio-similar which is also known as follow-on biologic or subsequent entry biologic is a biologic medical product that is almost an identical copy of an original product. Bio-similar are officially approved versions of original “innovator” products and can be manufactured. Although it is in reference to the similarity of medicinal products with the original generic medicines it becomes the most relevant study to bring our attention towards the Law of Individuality and Law of Similia in Homoeopathy.
Key Words: Individuality, Similarity, Bio-similar, Homoeopathy
Conflict of Interest. No conflict of Interest
Introduction
Individuality is the core concept for selection of medicine in Homoeopathy where it provides a process for identifying an individual to be most similimum with medicine. This process of Individualization is followed in the context of law of similia. Every aspect of understanding about the practice of homoeopathy follows the fundamental law of similia. It is within the law an individual has to be observed as most similar with the desired medicine. In its drug-proving, its study of the Materia Medica compiled from those proving; its examination of the patient and study of the case; its selection of the remedy and its conduct of whatever auxiliary treatment is required, it always seeks to individualize.
Homeopathy recognizes the individuality of each drug and substance in nature. Its method of testing or ‘proving’ drugs upon the healthy human beings is designed and used for the purpose of bringing out the individuality of each drug so that its full power and relations are established. Similarily during the process of case taking search are for the unique features within an individual to reflect the individuality. As no two human beings are alike it is most natural to see every individual in their most distinct way at every level of life. As we all have an individuality in health, we also have an individuality in disease. The signs and symptoms of a disease are nothing but the reaction of a person to the disease causing morbific agent or stimulus. Every person reacts to any external agent according to his/her individuality and so a person’s individuality is reflected in his/her disease too.
In organon of Medicine in aphorism 118 of Organon of Medicine it is observed as “Each medicine exhibits peculiar action on the human frame which are not produced in exactly the same manner by other medicinal substances of a different kind.” And again in the footnote to the aphorism 119, Dr. Hahnemann writes: “Anyone who has a thorough knowledge of, and can appreciate the remarkable difference of, effects on the health of man of every single substance from that of every other, will readily perceive that among them there can be no equivalent remedies, no surrogates.” It means there are no substitutes in the selection of a remedy. Either a medicine is indicated in a case or it is not. Symptomatic comparisons between similar drugs are carried out to find their individuality.
Bio- Similar Concepts
Bio-similar2 which is also known as follow-on biologic or subsequent entry biologic is a biologic medical product that is almost an identical copy of an original product. Bio-similar are officially approved versions of original “innovator” products and can be manufactured. Although it is in reference to the similarity of medicinal products with the original generic medicines it becomes the most relevant study to bring our attention towards the Law of Individuality and Law of Similia in Homoeopathy.
As in generic drugs of the more common small-molecule type, biologics generally exhibit high molecular complexity and may be quite sensitive to changes in manufacturing processes. Despite that heterogeneity, all biopharmaceuticals, including bio-similar, must maintain consistent quality and clinical performance throughout their lifecycle.
It has been observed in analytical studies that the biological product is highly similar to the reference product, despite minor differences in clinically inactive components, animal studies, including the assessment of toxicity, and a clinical study or studies. It is also in the assessment of immunogenicity and pharmacokinetics or pharmacodynamics2. They are sufficient to demonstrate safety, purity, and potency in one or more appropriate conditions of use for which the reference product is licensed and is intended to be used and for which license is sought for the biological product. The World Health Organization (WHO) published its “Guidelines for the evaluation of similar biotherapeutic products (SBPs)” in 2009. The purpose of this guideline is to provide an international norm for evaluating bio-similar.
Bio- Similar And Law Of Similia
Biologic products are an important treatment option for a wide array of conditions and diseases2, either to supplement small‐molecule drugs or as stand‐alone medications. The concept of developing biologic products that are “biosimilar” (highly similar) to the approved biologic products has aroused great interest worldwide, across government bodies as well as in scientific and medical communities2. Biosimilars may offer increased treatment options for patients and physicians, and may optimize efficiencies across healthcare systems. Therefore, bio-similars have the potential to provide lower cost alternatives and offer greater access to biologics, and thereby allow increased use of biologic therapies2.
In broad terms, a bio-similar is highly similar to a reference product in terms of structure and function. The development of bio-similars is associated with numerous challenges, including the proprietary nature of the production processes of the reference product and the complexity of biological molecules2.
Demonstrating bio-similarity requires rigorous evaluation of the proposed bio-similar including side‐by‐side comparison with the reference product. During the development of the reference product, the developer must conduct extensive preclinical studies and large clinical trials in all indications for which approval will be sought. However, for a biosimilar developer, the comparative analytical characterization and the demonstrated similarity between a proposed biosimilar and the reference product reduces the requirement for large clinical trials in all the indications approved for the reference product3.
Hahnemann Concepts on Discovery of Similar Medicine
In Organon of Medicine § 20 Fifth edition it is mentioned that “This spirit-like power to alter man’s state of health (and hence to cure diseases) which lies hidden in the inner nature of medicines can never be discovered by us by a mere effort of reason; it is only by experience of the phenomena it displays when acting on the state of health of man that we can become clearly cognizant of it. Further in § 25 “Now, however, in all careful trials, pure experience, the sole and infallible oracle of the healing art, teaches us that actually that medicine which, in its action on the healthy human body, has demonstrated its power of producing the greatest number of symptoms similar to those observable in the case of disease under treatment, does also, in doses of suitable potency and attenuation, rapidly, radically and permanently remove the totality of the symptoms of this morbid state, that is to say (§ 6 – 16), the whole disease present, and change it into health; and that all medicines cure, without exception, those diseases whose symptoms most nearly resemble their own, and leave none of them uncured.
The human body appears to admit of being much more powerfully affected in its health by medicines (partly because we have the regulation of the dose in our own power) than by natural morbid stimuli – for natural diseases are cured and overcome by suitable medicines. The human body appears to admit of being much more powerfully affected in its health by medicines (partly because we have the regulation of the dose in our own power) than by natural morbid stimuli – for natural diseases are cured and overcome by suitable medicines.
It is a natural phenomenon that Nature herself permits, as has been observed, the simultaneous occurrence of two (indeed, of three) natural diseases in one and the same body. This complication, happens only in the case of two dissimilar disease, which according to the eternal laws of nature do not remove, do not annihilate and cannot cure one another, but, as it seems, both (or all three) remain, as it were, separate in the organism, and each takes possession of the parts and systems peculiarly appropriate to it, which, on account of the want of resemblance of these maladies to each other, can very well happen without disparagement to the unity of life.
This therapeutic law of nature is rendered obvious to all and they are amply sufficient for our understanding. In spite of nature’s cure it is not always possible to have the same things being repeated again. Under such circumstances search for most similar medicinal substances are quite necessary to have therapeutic applicability of the law of similia.
In them he has producers of disease of all possible varieties of action, for all the innumerable, for all conceivable and inconceivable natural diseases, to which they can render homoeopathic aid – morbific agents (medicinal substances), whose power, when their remedial employment is completed, being overcome by the vital force, disappears spontaneously without requiring a second course of treatment for its extirpation, like the itch – artificial morbific agents, which the physician can attenuate, subdivide and potentize almost to an infinite extent, and the dose of which he can diminish to such a degree that they shall remain only slightly stronger than the similar natural disease they are employed to cure; so that in this incomparable method of cure, there is no necessity for any violent attack upon the organism for the eradication of even an inveterate disease of old standing; the cure by this method takes place by only a gentle, imperceptible and yet often rapid transition from the tormenting natural disease to the desired state of permanent health.
In synthesis, the homeopathic simile can be re-evaluated as a heuristic (finding) principle, a principle of biological and clinical research which assists in finding therapeutic strategies: in classic homeopathy, the ‘similars’ are those compounds which generate symptoms akin to those of the disease in all of its pathological, psychological and physiological complexity. The administration of the remedy to a sick organism would restore synchronism and cooperativity in cell enzymes, metabolic cycles, molecular feed-back loops, bioelectric potentials, with the consequence of higher cooperativity and more efficient energy handling.
Similar and Bio-Similar
The two approaches to system regulation—scientific/reductionist and homeopathic/holistic—are not conflicting, but use different approaches: mainstream pharmacology applies a ‘structural’ analogy, which is identified as the molecule binding to specific receptors or enzymes of the target system (if known). Classic homeopathy applies a ‘functional’ analogue, which is identified as the diluted compound that is able to regulate and/or to trigger homodynamic systems4. This kind of functional analogy, based on the similarity of symptoms, can be exploited even if the details of the receptors or the effector enzymes are unknown within the complex hemodynamic networks.
Mainstream pharmacology is much more precise when the exact mechanism of the disease is known, and specific drugs can therefore be administered. Homeopathy could be more effective when considering the complexity of the disease and subtle regulations. The homeopathic approach may be useful specifically because it does not focus on the cause of the disease, but on the teleology of the patient’s reaction. It is therefore not to be considered an alternative approach, but complementary to effective drug use4.
Conclusions
Despite many challenges, the development of bio-similar continues in earnest. Bio-similarity must be established based on the totality of evidence, from structural and functional assessment through nonclinical and clinical studies, adopting a tailored approach throughout development. It is clear that we must think differently when developing bio-similar, especially when defining CQAs and setting endpoints for nonclinical and clinical studies. The arrival of bio-similar challenges the healthcare community to learn and understand the scientific basis of similarity to the reference product using a stepwise approach. An increased awareness is needed to understand that clinical studies are a blunt instrument in the development of bio-similar, and that analytical evaluation is a far more sensitive tool in assessing similarity. The foundation of homeopathic medicine is the ‘Similia Principle’, also known as the ‘Principle of Similarity’ or also as the ‘Simile’, which reflects the inversion of pharmacological effects in healthy subjects as compared with sick ones.
REFERENCES
- S. Hahnemann, organon of Medicines, sixth Edition, Published by B. Jain Publishers, Noida,
- Carol F. Kirchhoff,corresponding author 1 Xiao‐Zhuo Michelle Wang, 2 Hugh D. Conlon, 3 Scott Anderson, 4 Anne M. Ryan, 5 and Arindam Bose 6, Biosimilars: Key regulatory considerations and similarity assessment tools, Biotechnol Bioeng. 2017 Dec; 114(12): 2696–2705. Published online 2017 Sep 19. doi: 10.1002/bit.26438,
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