The Days of ASCO - Biosimilars

Biologics are products that are made from living things - animals, humans, microorganisms. They are manufactured using bio-technology or other methods. They are usually large molecules, organic, complex mixtures and difficult to identify. Conventional drugs are chemical and their structures can easily be identified. Some examples of biologics are: Cytokines - interferon, Monoclonal antibodies - herceptin and vaccines. Biosimilars are biologics that are approved/ licensed by the FDA because they are highly similar to an already FDA approved drug. The FDA approved drug is called the reference product.

In the morning of Tuesday June 7,  I attended the ASCO session Biosimilars: Hear and Now
Speakers: Lemery, Weise, Esteva
 

Biologics have inherent molecular differences. They are not identical so they are not generics.Biotech/ drug companies with a biosimilar product must apply to the FDA for approval.
The general requirements are given below.

 

 Biosimilarity /interchangeability must be based on data from 

• Analytical studies
• Animal studies ( toxicity assessment) 
• clinical studies ( pharmaokinetics and pharmacodynamics

If a product is given a biosimilar designation in the US than the product must be prescribed by the health care provider and should not be substituted ( by the pharmacist) without the intervention of the health care provider.

Biosimilarity is determined using the totality of the evidence. Analytical comparisons are the foundation for determining that the products are highly similar . There is no need to to re-establish safety /effectiveness of the biosimilar product.

Dr Weise provided an overview of biosimilar use in the European Union. The EU has been using a similar process to approve biosimilars for the past 10 years. The example discussed during the session was Filgrastim, biosimilar to Neupogen.

But there are challenges to biosimilars in the US. There is the need to regulate, monitor and track the safety in patients. Will the biosimilar be covered by insurance?  Will providers be willing to prescribe the biosimilar with the limited efficacy and safety data compared to the original biologic.

Dr Esteva raised another question in his presentation. Will patients accept the biosimilar drugs? As patients in the US play a greater role in their care the safety data and efficacy data of the biosimilars must be communicated with patients effectively.   Currently in the US Zarxio, a biosimilar to Neupogen,  has FDA approval. In development by Pfizer and Amgen are biosimilars to Trastuzumab ( Herceptin) .

One benefit of the use of biosimilars is a lower cost( ~30% lower) .

As I listened to this session I kept wondering what I would do if in the future I was offered a biosimilar. As someone who has had issues after being prescribed generic medications I would definitely ask my doctor to see the  clinical studies used in the approval process.

Dee
Every Day is a Blessing!

Additional sources of information: 

FDA http://www.fda.gov/Drugs/DevelopmentApprovalProcess/HowDrugsareDevelopedandApproved/ApprovalApplications/TherapeuticBiologicApplications/Biosimilars/ucm241718.htm

Oncolink-http://www.oncolink.org/treatment/article.cfm?c=16&id=335

 

OC Awareness Month #8 -Treatments

Today I will review the treatment that a women diagnosed with ovarian cancer might receive. Of course every woman is different so your actual treatment might differ.

*A women diagnosed with ovarian cancer should see a  gynecologic oncologist ( gyn-onc) . Research has shown that women who receive surgery and treatment by a gyn-onc have higher survival rates.

There are different treatments offered to women diagnosed with ovarian cancer. Such as :

Surgery :
Hysterectomy- removal of the uterus and sometimes the cervix
Oopherectomy - removal of the ovaries and fallopian tubes
Oomectomey - removal of the oomentum the fatty covering of the abdomen
Lymph node biopsy-removal of lymph nodes which are examined for cancer

Chemotherapy:
Chemotherapy drugs disrupt the multiplication of cancer cells or kills them outright.The chemotherapy may be give IV, intravenously, where the drug is introduced into a vein or IP , intraperitoneal where the drug is introduced into the peritoneal cavity. Women may receive a combination of two drugs.

The most common drugs given to women with OC are carboplatin, cisplatin and paclitaxel. Additional drugs may be found on this NCI site http://www.cancer.gov/cancertopics/druginfo/ovariancancer.You might also receive targeted therapy , drugs or biologics. Targeted therapy will affect cancer cells but leave normal cells alone.

Radiation:
Radiation may be used to kill cancer cells in some cases of OC. The level depends on the type of OC cancer and stage of the disease.

 Source : http://www.cancer.gov/cancertopics/pdq/treatment/ovarianepithelial/Patient/page4


Tomorrow the stages of ovarian cancer

Dee
Every Day is a Blessing!

ASCO - Dose Dense Therapy, Neoadjuvant Therapy and Biologics

This will be my final report regarding my experience at the  ASCO 2012  meeting. 

Instead of personally writing about what I heard at  June second's Upfront Treatment of Ovarian Cancer an International Consensus and Variation Session Educational Session I thought it best to just share a link to a wonderful article ( plus it has cool graphics too) on the ASCO site . This session was presented by Drs. Armstrong ( IP therapy) , Fujiwara ( Dose Dense and Neoadjuvant  therapy)  and Rustin ( Parp inhibitors and Bevacizumab). You can tell how important the ASCO committee felt this was since it was held in  E Arie Crown Theater which seats over 4000 people.

So please click on the link below and read about those topics.

http://chicago2012.asco.org/ASCODailyNews/upfrontovarian.aspx

Dee
Every Day is a Blessing!