Home / Guidelines / Global biosimilars guideline development – EGA’s perspective

Global biosimilars guideline development – EGA’s perspective Posted 28/09/2009

Biosimilar guidelines and regulations are being developed all over the world, as outlined at the 7th EGA Annual Symposium on Biosimilars recently held in London, UK by Ingrid Schwarzenberger, Head Regulatory Affairs Biopharmaceuticals at Sandoz and member of European Generic medicines Association’s (EGA) European Biopharmaceutical Group.

Countries with biosimilar guidelines

  • In Turkey, a final guideline was issued in August 2008 by the General Directorate of Pharmaceuticals and Pharmacy, entitled Instruction Manual on Biosimilar medical products.
  • In Taiwan, a final guideline was issued on 21 November 2008 by the Department of Health, entitled Review Criteria for Registration and Market Approval of Pharmaceuticals-Registration and Market Approval of Biological Products.
  • In Malaysia, final guidance was issued on 30 July2008 by the Ministry of Health Malaysia, entitled Guidance Document for registration of Biosimilars in Malaysia.
  • In Australia, EU guidelines were adopted in August 2008.
  • In India a final guideline was issued on 11 July 2008, entitled Preparation of the Quality Information for Drug Submission for New Drug Approval: Biotechnological/Biological Products.
  • In Venezuela, a final guideline was issued on 3 August 2000, entitled SRPB-R Guidelines: application for Health Registry of DNA recombinant products, monoclonal and therapeutic antibodies, sub-classification for active substances already on the market.
  • In Brazil, a final guideline was issued on 26 October 2005 entitled Technical Rules for Registration of Biological Products.
  • In Colombia, a draft guideline was issued entitled License for Manufacturing facilities of biological products.
  • In Argentina, a draft guideline was issued in July 2008 by ANMAT, entitled Registration and registry modification of biological medicinal products.
  • In the Middle East, the consensus group recommended the implementation of the EMEA guidelines as the basis of Regional guidelines for the registration of biosimilars in the Near and Middle East.
  • In Saudi Arabia, draft guidance was issued in August 2008, entitled Drug Master File Requirements for the Registration of Biosimilars.
  • In Mexico, a draft guideline was issued on 9 October 2008 entitled Ley general de medicamentos biotecnológicos.
  • In Canada, a second draft guideline on Subsequent-Entry Biologics was issued in March 2009, which was open for comments for 60 days (26 May 2009): “… in appropriate circumstances, a biologic product that is not authorised for sale in Canada may be used as a reference product …”.
  • WHO developed two draft versions in 2008. WHO‘s draft guideline has an EU-modelled ‘biosimilar pathway’ and a controversial ‘alternative’ pathway; the next draft guidance is to be expected after the WHO Meeting in October 2009. According to the WHO, a reference product is a “… previously approved reference medicinal product for which there is a substantial public record of safety and efficacy, … a medicinal product that was licensed on the basis of a full data package …”.
  • The EU has a legal basis for biosimilars, published with Directive 2001/83/EU, as amended with Directive 2004/27/EU. A reference product requires the use of a reference product authorised in the EU to be used for the entire comparability exercise.
  • In Japan, a final guideline was issued on 4 March 2009; a reference product is “a biosimilar product … which has comparable quality, safety and efficacy to a … biotechnology-applied … product that has been approved in Japan …”.
  • In the US, there are several bills now before Congress, including Waxman HR 1427 and Eshoo HR 1548; all bills require an FDA-approved biological reference product, thus mandating testing against US reference products.

Jurisdiction hurdle
As pointed out by Ms Ingrid Schwarzenberger, the European regulations, the Japanese guideline, and probably also the future US legislation, require the use of a reference product authorised in their jurisdiction. This would mandate the performance of separate, full-development programmes for each ICH country/region utilising the reference products authorised in each region. ICH stands for ‘The International Conference on Harmonisation of Technical Requirements for Registration of Pharmaceuticals for Human Use’.

“This is unnecessary, unethical (because it requires duplication of preclinical and clinical studies) and uneconomical,” stressed Ms Schwarzenberger. “Reference products are often the same or highly similar in different countries, even though licensed under different jurisdictions. Often, documentation is available in the public domain, confirming that the products are the same. Comparability of reference products of one original manufacturer from different highly regulated countries (EU, US) can be clearly established by stringent analytical and functional studies. Under these premises it should not be required to duplicate preclinical and clinical studies for each country or region.”

According to Ms Schwarzenberger, there should be a way to let a science-based approach towards global development overcome the regulatory burden. “The first step should be the obligation by applicants to show comparability between a biosimilar and the relevant reference products. The next step (if necessary) should be the exchange of information on reference products between regulators in the context of confidentiality agreements. The importance of this issue is demonstrated by inclusion of biosimilar development into the ‘EU-FDA Transatlantic Simplification Initiative’. The current pharmacovigilance activities require ‘single identification of medicines’. Global development is a must to remain competitive and financially viable. It is the only way to improve worldwide availability, affordability and access to biosimilars,” she concluded.

Source: EGA

Comments (15)

We offer fresh cut bank instruments for lease and sales posted 22/07/2016 - by Devdutt Vyas

We specialized in Bank Guarantee {BG}, Standby Letter of Credit {SBLC}, Medium Term Notes {MTN}, Confirmable Bank Draft {CBD} as well as other financial instruments issued from AAA Rated bank such as HSBC Bank Hong Kong, HSBC Bank London, Deutsche Bank AG Frankfurt, Barclays Bank , Standard Chartered Bank and others on lease at the lowest available rates depending on the face value of the instrument needed. We deliver with time and precision as sethforth in the agreement. Our terms and Conditions are reasonable, below is our instrument description. The procedure is very simple; the instrument will be reserved on euro clear to be verified by your bank, after verification an arrangement will be made for necessary bank documents and stock testing expenses, the cost of the Bank Guarantee will be paid after the delivery of the MT760. Below is our instrument description. DESCRIPTION OF INSTRUMENT: Instrument: Bank Guarantee (BG/SBLC). Total Face Value: Minimum of 1M Eur/USD (One Million Eur/USD) to Maximum of 5B Euro/USD(Five Billion Eur/USD). Issuing Bank: HSBC London, Barclays Bank, Deutsche Bank Frankfurt, Hong Kong, Any AA rated Bank in Europe or any Top 25 WEB. Age: One Year, One Day Leasing Price: 5% of Face Value plus 2% commission fees to brokers. Delivery: Bank to Bank SWIFT. Payment: MT-760. Hard Copy: Bonded Courier within 7 banking days. All relevant business information will be provided upon request plus our terms and procedures: If you are interested please contact me for us to proceed further Regards Devdutt Vyas Email: devdutt_vyas@outlook.com devdutt.vyas2016@gmail.com Skype: devdutt.vyas

Carolyn V. Metnick posted 17/07/2016 - by elvinloancompany@yahoo.com

HOW I GOT MY LOAN FROM ELVIN LOAN COMPANY{elvinloancompany@yahoo.com} I am Carolyn V. Metnick,from Ohio USA, i want to use this great medium to announce this lender Elvin Morrison who is really a God sent to my family. few months back i was in search of a loan from the internet where i was scammed of $3250.00, i never thought i will ever apply for a loan on the internet again before i met a post about this lender made by one Maury who also got a loan from them, then i took a try again, after loan processing i was ask to provide my banking details which i did and to my greatest surprise i was granted a loan of $45,000.00 at first i thought it was a joke until i got to the bank to confirm and it was true, i was overwhelmed with joy. so i want you all who desire a loan and are capable of paying back the funds at the due time to contact: elvinloancompany@yahoo.com or on page http://elvinloancompanys.bravesites.com or Tel:+13072132540 and be a partaker of my testimony ....

loan offer posted 12/07/2016 - by joselonganfirm88@gmail.com

Do you seek funds to pay off credits and debts? Do you find yourself in a bit of trouble with unpaid bills and don’t know which way to go or where to turn? What about finding a reputable Debt Consolidation firm that can assist you in reducing monthly installment so that you will have affordable repayment options as well as room to breathe when it comes to the end of the month and bills need to get paid? JOse Loan Company is the answer. Email (joselonganfirm88@gmail.com) We offer the following types of loans *Debt Consolidation Loans *Business Loans *Personal Loans *Home Loans *Car Finance *Commercial Loans *Investments Loans *E.T.C Note: We give you loan with a low interest rate of 3% and loan duration of 1 to 20 years to pay back the loan (secure and insecure). Do not keep your financial problems to yourself in order for you not to be debt master or financial stress up, which is why you must contact us quickly for a solution to your financial problems. It will be a great joy to us when you are financially stable. Email { joselonganfirm88@gmail.com }

THANK GOD FOR MY LIFE. posted 08/07/2016 - by jarmila

Hi,i am Jarmila From Texas U.S.A, I quickly want to use this medium to share a testimony on how God directed me to a Legit and real loan lender who has transformed my life from grass to grace, from being poor to a rich man who can now boast of a healthy and wealthy life without stress or financial difficulties.After so many months of trying to get a loan on the internet proved abortive,i was frustrated and i lost hope because i had bad credit and even the banks turned me down,then i heard of my friend who got his loan online from a loan company then i decided to contact him to hear from him, we discussed about the issue and to our conclusion he told about the loan firm called RAPID RESPONSE LOAN FIRM, So i visited the website and applied for a loan sum of (500,000.00USD) with low interest rate of 2%,The loan was approved easily without stress and all the preparations where made concerning the loan transfer and in less than 12 hours, the loan was transfered to my account, if you are interested or need more information, please visit the website at (http://rapidresponseloanfirm.my-acct.com) or email them at rapidresponsecustomer@my-acct.com, rapidresponseloanfirm009@gmail.com . They may not know am doing this but i pray that God will bless them for the good thing they have done in my life and i strongly believe other persons are testifying.

HEY GUYS posted 04/07/2016 - by IMELDA DAHER

Hey guys, my name is Imelda Daher from Philippines but reside in America i am very happy that i was able to be online last week when Janet posted on YouTube that she has finally gotten what she wanted for her marriage life after all the stress she went through trying to hack into our husbands phone herself.. So after that I decided to try and see if it’s gonna work or still the same thing I see online everyday so I contacted Michael as i was referred to by Janet to his email which I did and got his direct telephone number as well too and believe me he did a good job for me that I was shocked when I got the information I needed that my dear husband for 10 year of marriage has a baby mama in Sweden. thanks to Michael Lawson for this great job even if it’s gonna break my home its better than been fooled for the rest of my life. lawsonmichael33@yahoo.com by Janet and he did a good and fast job for me in less than 48hrs...he made available phone hack, chat histories, present chats and future chats...You can also contact him for all sorts of mobile hacking jobs like he told me. Good luck to everyone who really wanna work with him and put a stop to the entire nightmare.

elvinloancompany@yahoo.com posted 02/07/2016 - by Andy James

My name is Andy James currently living in California USA Am writing this letter because am really grateful for what Elvin Morrison did for me and my family when I thought there was no hope he came and make a way for me and my family by lending us loan at a very low interest rate of 2%. I never thought that there are still God sent and genuine loan lenders on the web but to my greatest surprise i got my loan without wasting much time so if you are out there looking for a loan of any amount i would like to recommend you to Elvin Morrison the Managing director of Elvin Loan Company because he is a God sent man that can change your life forever, So if you really want to make a better life without any fund scarcity I would advise you to get in touch with him through this e-mail below elvinloancompany@yahoo.com or call on +13072132540 or on our web page http://elvinloancompanys.bravesites.com

LOAN OFFER posted 01/07/2016 - by Andy James

My name is Andy James currently living in california USA Am writing this letter because am really grateful for what Elvin Morrison did for me and my family when I thought there was no hope he came and make a way for me and my family by lending us loan at a very low interest rate of 2%. I never thought that there are still God sent and genuine loan lenders on the web but to my greatest surprise i got my loan without wasting much time so if you are out there looking for a loan of any amount i would like to recommend you to Elvin Morrison the Managing director of Elvin Loan Company because he is a God sent man that can change your life forever, So if you really want to make a better life without any fund scarcity I would advise you to get in touch with him through this e-mail below elvinloancompany@yahoo.com or call on +13072132540 .

WE OFFER ALL KIND OF LOANS - APPLY FOR AFFORDABLE LOANS. posted 23/06/2016 - by Mrs. Ceren

WELCOME TO PERGO CORPORATE FINANCE,(PCF), pergocf@fastservice.com aims is to provide Excellent Professional Service. Are you a business man or woman? Are you in any financial mess or do you need funds to start up your own business? Do you need a loan to start a nice Small Scale and medium business? Do you have a low credit score and you are finding it hard to obtain capital loan from local banks and other financial institutes?. Our loans are well insured for maximum security is our priority, Our leading goal is to help you get the services you deserve, Our program is the quickest way to get what you need in a snap. Reduce your payments to ease the strain on your monthly expenses. Gain flexibility with which you can use for any purpose – from vacations, to education, to unique purchases We offer a wide range of financial services which includes: Business Planning, Commercial and Development Finance, Properties and Mortgages, Debt Consolidation Loans, Business Loans, Private loans, Home Refinancing Loans with low interest rate at 1.00% per annul for individuals, companies and corporate bodies. Get the best for your family and own your dream home as well with our General Loan scheme. WE OFFER ALL KIND OF LOANS - APPLY FOR AFFORDABLE LOANS. Please, contact us for more information: pergocf@fastservice.com Kindly write us back with the loan information; - Complete Name: - Loan amount needed...$, €, £: - Loan Duration: - Purpose of loan: - City / Country: - Telephone: - Name of the Site: If you are interested to get a loan then kindly write us with the loan requirement. Please, contact us for more information: pergocf@fastservice.com Yours Sincerely, Mrs. Ceren Kelly pergocf@fastservice.com We look forward to hear from you ASAP Interested applicants should Contact us via email: pergocf@fastservice.com

Lakewood Financial Institutions posted 16/06/2016 - by loan offer

Do you need a loan to start up business or to pay your bills and a corporate financial for real estate and any kinds of business financing. LAKEWOOD FINANCIAL INSTITUTIONS also offer Loans to individuals,Firms and corporate bodies at 2% interest rate. LAKEWOOD give out loan to serious minded people that are interested of loan if interested contact this email:lakewook21@gamil.com or lakewook23@yahoo.com and lakewook_financialinstitutions@consultant.com

Testifying on how me and my lovely husband got our dream loan. posted 15/06/2016 - by Pasqualina Lattanzio

I will like to ask this question before i go straight to my public announcement out here. If getting a legit loan online was so easy as stated in all this fabricated / duplicated loan testimonies that i have been reading through online, then why was i and my lovely husband turned down for a loan online five times after been scammed of about $42000 Australian Dollars? We the loan seekers are the common regular victims of this fake loan stories simply because we are in dire needs we believe in their stories out of desperation and sometimes frustrations to get a loan, but at the end of it all we find out that we have gained nothing but rather loosed the little we have into the hands of this online scammers who claim to be real and reliable loan lenders. The last loan lenders that ripped us off our hard earned money asked us to pay some few amount worth $800 dollars for insurance because they said that we were on high risk. How is that? I still don't understand. how can a lender be requesting several fees from a borrower? if that borrower was having money would he or she have come along to ask for a loan? those lenders deceived my husband and i of getting a loan and we thought it was all real because we never believed that there was anything as an online loan scam and they had us pay all we had to them and due to the way things were moving we had to close out our business over here in Australia as we could not meet up with the customers needs any longer because we sold all most every single thing we had and we could not replace them as we thought that we could do so if we get our requested loan amount. In a lay man language, YES !! we were scammed by almost six different lenders online, Before a customer who was a closed friend to my family saw the way things were so bad for us and decided to introduce us to a private loan company that was registered and accredited by the government.But frankly speak-en, we refused any further loan offer because we had concluded that all of them were scams and the same but he insisted as he opened up to me and my husband how he got a loan from the loan firm he narrated to us that he has so much and high integrity in granting loans to the world. He also told us that this loan firm called Derek Barlow Loan company is a reliable and a reputable loan firm know in the world for reliable work. After this our family friend called Marin Carl has told us so much about this loan firm, I and my lovely husband had no other option than to believe him, because we knew him from the onset to be a man of unquestionable characters who was always known for his words and we applied with this company that he called Derek Barlow Loan Firm but prior to our application with this email address: derekbarlowloans@yahoo.com , that he provided to us to contact the reliable loan firm, Without fear that we are applying for a loan from a firm that will not scam us out of our hard earned money like others. It was to my own satisfaction and i applied but God was so kind that he lead us through and we got our loan after meeting with the terms and conditions this loan firm and we follow up with the non-collateral loan process and meet up with the requirement in getting our loan. Am by name Lattenzio Pasqualina and you can send me an email on the following email address: which is my private email address if you need more clarification. Because i am ready to do all that is within my reach to let the whole world know that Derek Barlow Loans is the only real and existing loan firm online that can grant you loan without any form of scam activities. You will also find my identity card on some of my post to let everyone that need loan know that Derek Barlow Loan is the only real and reliable loan firm online in the world that could grant us our dream loan amount of $456000 Australian Dollars.

get a loan posted 11/06/2016 - by david

Get a Loan Today At 3% Interest Rate, contact us at:davidloans760@gmail.com Welcome to DAVID JAMES Loan Company, This is a legit loan Company, formed to help individuals who are in need of financial crises and help them achieve their goals in life. Available Loans we offer are, 1. Personal Loans (Secure and Unsecured) 2. Business Loans (Secure and Unsecured) 3. Combination Loan 4. Consolidation Loan And Many More: Interested clients should please send request to our email for application form and terms. Try and see for your self, our wonderful services that does not exceed Working days for loan processing and just only (1)hour 35 minutes of loan Transfer. EMAIL---[ davidloans760@gmail.com ] Warm Regard

Clydesdaleloancompany@yahoo.com posted 30/05/2016 - by Jayden Logan

My names are Jayden Logan, I am from New York, United State, am here to testify on how i got my loan from George Clydesdale {Clydesdaleloancompany@yahoo.com} after i applied from various loan lenders who claimed to be lenders right in this forum,i thought their lending where real and i applied but they never gave me loan.I would like to bring this to the notice of the public about how i met George Clydesdale, after i lost my job and being denied loan by my bank and other financial institution due to my credit score. I could not pay my children's fees. I was behind on bills, about to be thrown out of the house due to my inability to pay my rent, It was during this period my kids were taken from me by foster care. Then i set out to seek for funds online where i lost $3,670 that i borrowed from friends which i was rip off by some scam claiming to be loan lenders. Until i read about George Clydesdale Loans {Clydesdaleloancompany@yahoo.com} or visit there webpage http://georgeclydesdaleloans.bravesites.com/ where i was granted a loan to pay up my debts and to start up a business. You can as well give them a call: +1(631) 791-5709. Why am i doing this? I am doing this to save as many that are in need of a loan not to be victim of scams on the internet. Thanks Jayden Logan

How I Was Rescued By A God Fearing And Trusted Lender {Lexieloancompany@yahoo.com}.. posted 20/05/2016 - by Andrew Thompson

Hello, I am Andrew Thompson currently living in CT USA, God has bless me with two kids and a lovely Wife, I promise to share this Testimony because of God favor in my life, 2days ago I was in desperate need of money so I thought of having a loan then I ran into wrong hands who claimed to be loan lender not knowing he was a scam. he collected 1,500.00 USD from me and refuse to email me since then I was confuse, but God came to my rescue, one faithful day I went to church after the service I share idea with a friend and she introduce me to LEXIE LOAN COMPANY, she said she was given 98,000.00 USD by MR LEXIE , THE MANAGING DIRECTOR OF LEXIE LOAN COMPANY. So I collected his email Address , he told me the rules and regulation and I followed, then after processing of the Documents, he gave me my loan of 55,000.00 USD... well if you are interested in a loan you can as well contact him on this Email: Lexieloancompany@yahoo.com or call/sms on: +18168926958 thanks, I am sure he will also help you.

Affordable Loan To Get Your Financial Problem Solved { Clydesdaleloancompany@yahoo.com } posted 19/04/2016 - by Tarsha Dannis Bank

Affordable Loan To Get Your Financial Problem Solved { Clydesdaleloancompany@yahoo.com } Hello everybody, I am Tarsha Dannis Bank, from Mississippi ,Ontario USA. I am a widow at the moment with two kids and i was stuck in a financial situation and i needed to refinance and pay up my bills and buy a house here in Oklahoma. I tried seeking for loans from various loan lenders both private and corporate but never with success, and most banks declined my credit. But as God would have it way, i was introduced to a lender Called George Clydesdale by a friend named Adam Ken Fisher who got a loan from them and contacted them as instructed and to my greatest surprise, i got a loan sum of $349,000.00 and today am a house owner and my kids are doing well. So my friends, if you must contact any lending company with reference to securing a loan with low interest rate of 3% and better repayment plans, contact George Clydesdale Loans LLC ( Clydesdaleloancompany@yahoo.com ) He offers all kinds of loans You can contact him through his email via: ( Clydesdaleloancompany@yahoo.com ) or Tel: (347) 708-8926 or visit there webpage http://georgeclydesdaleloans.bravesites.com/

How I Was Rescued By A God Fearing Lender (Lexieloancompany@yahoo.com) posted 10/04/2016 - by Andrew Thompson

Hello, I am Andrew Thompson by Name currently living in CT USA, God has bless me with two kids and a lovely Wife, I promise to share this Testimony because of God favor in my life, 2days ago I was in desperate need of money so I thought of having a loan then I ran into wrong hands who claimed to be loan lender not knowing he was a scam. he collected 1,500.00 USD from me and refuse to email me since then I was confuse, but God came to my rescue, one faithful day I went to church after the service I share idea with a friend and she introduce me to LEXIE LOAN COMPANY, she said she was given 98,000.00 USD by MR LEXIE , THE MANAGING DIRECTOR OF LEXIE LOAN COMPANY. So I collected his email Address , he told me the rules and regulation and I followed, then after processing of the Documents, he gave me my loan of 55,000.00 USD... So if you are interested in a loan you can as well contact him on this Email: Lexieloancompany@yahoo.com or call +1(406)946-0675 thanks, I am sure he will also help you.