Biosimilars and recombinant drugs

by pragsmbagmailcom (student)

University Degree Subjects allied to Medicine

1. Biosimilars:

Biopharmaceuticals are defined as protein drugs synthesized by recombinant biotechnology with the use of bacteria, virus, plant and animal cells. Biopharmaceuticals have created miracles in disease treatment since the time they have been launched and created wonders in the treatment of diseases which had no remedy earlier example orphan diseases (Nowicki, 2007). Biopharmaceuticals have been in use vastly since their emergence however, the expiration date of these drugs has become a huge concern in medical care.

Biosimilars (In Europe) or Follow-on biologics (In USA) are biopharmaceuticals which resemble biopharmaceuticals in their activity, but differ in the physical and chemical properties. They are considered to be the cheaper versions of biopharmaceuticals and claimed to be tested to elicit similar biological activities as that of original biopharmaceuticals (Covic and Kuhlmann, 2007).

Some of the first examples of Biosimilars available in the market include Omnitrope, biosimilar to Genotropin and Valtropin which is biosimilar to Humatrope (Nau, 2006; Burger, 2006). There are many Biosimilars being developed in the market which are waiting to be approved.

POTENTIAL MERITS AND DEMERITS OF BIOSIMILARS:

MERITS: Biosimilars had come as a boon to the biologists when there was a concern of biopharmaceuticals patent expiration. They are cheaper versions eliciting the same biological effects as that of original biopharmaceuticals. They help in treatment of many orphan diseases.

DEMERITS: Biosimilars are not identical with biopharmaceuticals in structure, manufacturing and purification. There are many potential problems identified with Biosimilars which include:

Patient safety and Immunogenecity: As biosimilars are not similar to biopharmaceuticals, the potential risk associated with them is also different. Immunogenecity associated with these protein products ...

This is a preview of the whole essay

POTENTIAL MERITS AND DEMERITS OF BIOSIMILARS:

DEMERITS: Biosimilars are not identical with biopharmaceuticals in structure, manufacturing and purification. There are many potential problems identified with Biosimilars which include:

Patient safety and Immunogenecity: As biosimilars are not similar to biopharmaceuticals, the potential risk associated with them is also different. Immunogenecity associated with these protein products is not similar and hence clinical studies In human population has to be done before approval. (Nowicki, 2007).
Substitution and patient acceptance: The Biosimilars do not resemble originals in bioavailability and has narrow therapeutic window which may cause rejection and intolerance from patients and physicians from substitution (Nowicki, 2007).
Naming and regulation: WHO-INN system is currently following the same naming system to Biosimilars as that of biopharmaceuticals and discussions are pending to change this system to avoid confusion (Nowicki, 2007). Additionally regulations by EMEA and FDA are improving directions for approval of these Biosimilars (Covic and Kuhlmann, 2007).
Labeling: Since the safety instructions and composition is different for both, labeling instructions should differ (Nowicki, 2007).

2. Tier-4 Drugs:

Tier 4 drugs are defined as those drugs employed in treatment of cancer and other chronic disorders, which could prove fatal. Examples of this type include Avastin (Bevacizumab) and Herceptin (trastuzumab).

Tier-4 drugs are used intensively in chronic disorders and cancers. They reduce the intensity of chronic conditions by increasing the life span and health condition of patients suffering from it.

MERITS AND DEMERITS OF TIER-4 DRUGS:

MERITS: The primary merit of these biologicals is improvement of patient condition and relief of patient symptoms in chronic conditions. Treatment without these drugs tends to be impossible for physicians and patients (Thomas et al., 2008).

DEMERITS:

Financial factors: The major pitfall associated with these drugs is high cost in use and manufacturing. Due to the rising costs and co-insurance policy, patients will have to pay 20-33% of total medical costs against the policy of fixed payment and hence has become a major financial consideration for many patients (Thomas et al., 2008).
Clinical, ethical sense in covering drugs: Many drugs are treated the same way regardless of the activity it provides. For example Avastin did not show any improvement in patient condition but another adjuvant drug Herceptin, decreased deaths due to breast cancer. Both of these drugs are treated the same way, which decreases cost effectiveness (Thomas et al., 2008).

INCREASING COSTS OF RECOMBINANT DRUGS:

The use and value of recombinant drugs is increasing day to day, and health agencies in UK and USA have responded tremendously to this.

Recombinant drugs and their variants are becoming extremely expensive and has become a challenge to both the governments.Keeping pace with the growing technology and health care needs has become a challenge to both the governments (Peter and Philips, 2007).

To address the situation, US government has strategically improved its health care plans in investing funds for research and development organizations for inventing follow on biologicals. This approach would be cost effective and rightly address the problem. Apart from initial funding, US and UK governments are planning to support more in further research of their improvement (Peter and Philips, 2007).

Another significant development by medicare is pay for performance to increase health care standards where money is paid according to performance shown (Alan et al., 2008).

REFERENCES:

1. Michal,N. (2007) Basic Facts about Biosimilars. Kidney Blood Press Res .230,

pp.267–272.

2. Nau, J.Y. (2006) Omnitrope, first ‘biosimilar’ drug of the European Union. Rev Med Suisse. 2, pp.1206.

3. Thomas, H., Lee, M.,Ezekiel, J., Emanuel, M. (2008) Tier 4 Drugs and the Fraying of

the Social Compact. Engl j med .359, pp.4.

4. Burger, J. (2006) The first approved biotech-generic. Versicherungsmedizin. 58, pp.

190–191.

5. Covic,A., Kuhlmann, M.K. (2007) Biosimilars: recent developments. Int Urol

Nephrol .39, pp.261–266.

6. Alan, M.G., Mark, B.M. (2007) Satisfaction Guaranteed — “Payment by Results” for

Biologic Agents. Engl j med .357, pp.16.