Sandoz has recently gained FDA approval for the 1^st and only denosumab biosimilars.

1. Denosumab is a bone anti-resorptive (slow down bone loss) drug.  It is effective in addressing both primary and secondary bone loss, including conditions like osteoporosis. 
2. Osteoporosis is a condition in which bones become weak and brittle. The body constantly absorbs and replaces bone tissue. With osteoporosis, new bone creation doesn't keep up with old bone removal.

 About Biosimilars 

1. A biosimilar is a biologic medical product that is almost identical to an original product. 
2. Biosimilars are manufactured using the same raw materials and manufacturing techniques as the original biological product.
3. Biosimilars are approved versions of original ‘innovator’ products and can be manufactured when the original product's patent expires.
4. They are approved by demonstrating their high similarity to an already approved biologic product, known as a reference product.
5. Biosimilars share the same treatment risks and benefits as biologic medicines.
6. Biosimilars offer the advantage of increased access to lifesaving medications at potentially lower costs.
7. Biosimilars are more complex to manufacture compared to small-molecule generic medicines.

 Difference between Biosimilars and Generics 

Biosimilars	Generics
Involve creating equivalents of biological entities	Involve replicating chemical entities known as Active Pharmaceutical Ingredients (APIs)
Require engineering organisms for therapeutic effect	Can simply produce copies of the API
More complex in structure and manufacturing processes	Less complex compared to biosimilars
Regulatory approval is more complex compared to generics	Regulatory approval is less complex than for biosimilars
Trickier to copy due to complexity and potential structural differences	-

 Prospects of Biosimilars 

1. The growth of biologics, especially for cancer, diabetes, and autoimmune diseases, has created a global opportunity for biosimilars.
2. Indian pharmaceutical companies are investing heavily in biosimilar development and production to gain a competitive advantage.
3. In 2014, Zydus Cadila made history by launching the world’s first biosimilar of Adalimumab, a drug used to treat rheumatoid arthritis and other autoimmune disorders, originally patented by AbbVie.

• Rheumatoid arthritis (RA) is a chronic (long-lasting) autoimmune disease that mostly affects joints. 
• Autoimmune diseases occur when the immune system attacks healthy cells in the body. 

4. Biosimilars offer a cheaper option compared to biologics, making treatment more accessible to patients.
5. Patent expirations of certain biologics, along with upcoming ones, create an opportunity to close the gap with biosimilars.
6. Biosimilars can aid in battling diseases like cancer, asthma, and arthritis in developing countries, improving public health.
7. Promoting biosimilars and complex generics production can help tackle the increasing prevalence of non-communicable diseases globally.
8. The biosimilars industry provides a platform for pharmaceutical companies to innovate, succeed, and generate revenue while addressing crucial healthcare needs.

Active Pharmaceutical Ingredients (APIs) APIs are the essential elements in a pharmaceutical drug that cause the necessary effect on the body for treating a condition. Chemical compounds undergo processing to produce APIs. In a biologic drug, the active ingredient is termed a bulk process intermediate (BPI). In drug development and manufacturing, APIs are crucial active elements interacting with specific receptors or target molecules in the body to achieve the desired physiological or therapeutic response. All drugs consist of two fundamental parts: (1) Active Pharmaceutical Ingredient (API), the core ingredient, and (2) excipients. Excipients are substances, other than the drug, aiding in delivering the medication into your system. Chemically inactive substances like lactose or mineral oil serve as excipients. These materials contribute to maintaining the stability of the medication and controlling absorption when taking the drug.

Must Check: Best IAS Coaching In Delhi