Biosimilars Biologics

Question 1

What are biologics

Answer 1

Large proteins that are antibodies and a fusion of proteins produced by techno in living cells

Taregted at cell surface receptors and enzymes for chronic conditions

Question 2

Difficulty of synthsesing

Answer 2

Biologics have high specificity but are difficult to synthesise.
The graph on the lecture shows how much larger the biologics are.

Question 3

Porcine vs human insulin

Answer 3

There is a biological equivalence.
Both cause a similar reduction as seen via the graph in the lecture.

Question 4

Chronic kidney disease: managing anaemia and whybthey drugs are** BIOSIMILARS AND NOT GENERICS**?

Answer 4

The use of EPO hormone, its Mwt is 30,000.
Big list of different formulations.
**
HSA (Human serum albumin), regulatory authorties said it was not safe to use this and thus modified it and had HSA-free.
Eprex realised that there was a higher incidence when removing HSA.

Due to the patient forming antibodies against that Eprex that was HSA free and formed pure red cell aplasia

Therefore for the biologics this doesnt apply for having cheaper drug prices because nobody understood why it happened, which means for any drugs that comes on to the market you need to monitor safety long term which costs alot of money.

Thus the pharma company need to charge more, and the government recognise the value of their drugs.

Question 5

For eprex you need to know the whole production process in order to be **accurately described **

Answer 5

• Choice of sequence
• Cloning
• Expresion in host cell
• Fermentation
• Purification
• Formulation
• Even tank size affects the glycoside

Question 6

Less attractive to generic companies

Answer 6

As a result of a larger descrpition and better defined, as well as more tests needed, regulatory processing has lengthened.
=Less attractive, no incentive to reduce price.

Question 7

Various types of anaemia

Answer 7

Many different glycosyaltion patterns.

Epoetin consists of several different forms and different biological properties.

• Sugar residues of 3 different parts of EPO.
• Glycosylation pattern influences the ability of the haem EPO to increase the production of RBC.
• Can also extend the half life and biological activity.

Question 8

Biosimilar Epoetin:Gaps in quality and potential safety

Answer 8

These drugs are very expensive because not many people can produce compounds that work and show they work.

Despite the limited data on the efficacy and safety of biosimilar Epoetin, many countiresproduced EPO and were tested against EU standards using EPO-alpha as the reference.
Using in vitro/in vivo

* 7/31 exceeded pH
* In vitro 11 exceeded the spec
* In vivo potency, 7 failed
* Bacterial endotoxin 2/31