Free Sale Certificate vs CPP

CPP已取代Free sale certificate

 

	What is a batch?
	Does Missionpharma prequalify all manufacturers?
	Does Missionpharma hold a certificate of Good Distribution Practice?
	How do you handle a claim from a customer?
	Is there a difference in quality between generic drugs from different sources?
	What is a Manufacturing license?
	What is a GMP-certificate?
	Why is a GMP certificate not enough?
	What is a Free Sale Certificate?
	What is a CPP (Certificate of Pharmaceutical Product)?
	What is a Certificate of Analysis?
	What is a Certificate of Origin?

ps. Export licence

 

	What is a batch?
	A batch is a defined quantity of a product involving all used materials from raw material to packing material. This is to ensure a homogeneous product for each batch.

 

 

	Does Missionpharma prequalify all manufacturers?
	Yes, we prequalify all our manufacturers. We run a comprehensive prequalification system, which is managed by our QA/QC team. All manufacturers are validated based upon specific criteria in our prequalification system and only manufacturers that meet our standards are approved.

 

 

Does Missionpharma hold a certificate of Good Distribution Practice?

Yes, Missionpharma is approved and registered by the Danish Medicines Agency as a distributor of pharmaceutical products. This approval is only granted to distributors who satisfy the regulations laid down by the Danish Medicines Agency on professional knowledge, organisation and operation. Therefore, Missionpharma conforms to the requirements for good distribution practices as recommended by the European Community. Missionpharma is inspected every two years by the Danish Medicines Agency. Download GDP certificate.

 

 

How do you handle a claim from a customer?

We ensure that all complaints from our customers are investigated thoroughly and professionally according to detailed Standard Operating Procedures (SOPs). Our investigation starts immediately after receipt of the complaint and includes a review of internal product specifications and/or product file, the quality control document and the certificate of analysis.   This is followed by re-testing of the product, using a laboratory accredited according to ISO/IEC 17025 or approved by European authorities. In a situation where the conclusion is that Missionpharma or the manufacturer has caused the product not meeting specifications, the claim is accepted without further notice. In such an instance it is ensured that the appropriate corrective measures to prevent recurrence of the problem are taken.

 

 

	Is there a difference in quality between generic drugs from different sources?
	Yes. There can be a significant difference regarding aspects such as choice of raw material, type of coating, shelf-life, packing and labelling. Any medical wholesaler should be aware of these differences and should be able to provide you with documentation to substantiate the quality level you require.

 

 

	What is a Manufacturing license?
	A manufacturing licence is an official authorisation issued by the national health authorities to a pharmaceutical manufacturer allowing the company to manufacture a certain range of pharmaceutical products according to current laws and orders. The certificate is normally issued in the local language and is generally not meant to be handed out to a third party.

 

 

	What is a GMP-certificate?
	A GMP-certificate is issued by the national health authorities and generally summarises the contents of the manufacturing license in one page. The certificates states: That the company in question has a manufacturing license That the company is inspected regularly by the national health authorities That the company complies with Good Manufacturing Practice (GMP).

 

Why is a GMP certificate not enough?

A GMP certificate itself is no guarantee for GMP compliance, as it highly depends on how the GMP regulations are interpreted by the national health authorities. Furthermore, a GMP approval does not cover the manufacturer’s capability to maintain consistency in the used API quality, in-process controls and other routines in the daily production and controls.   Therefore, in order to ensure compliance with GMP guidelines, it is of fundamental importance that on-site audits are performed.

 

 

What is a Free Sale Certificate?

A Free Sale Certificate is issued by the national health authorities for a specific product, stating that the product is for "free sale" within the country of origin. This does not necessarily mean that the product is licensed to be placed on the market in the country of origin, but that the product is of a quality suitable for being placed on the market. In other words, a Free Sale Certificate does not guarantee that the product in question is marketed in the country of origin.

 

 

What is a CPP (Certificate of Pharmaceutical Product)?

A CPP is a certificate issued by the national health authorities upon request from either the manufacturer, the customer or the authorities in the importing country. The certificate is issued for a specific product and states whether or not the product is marketed in the country of origin. Furthermore, it states that the manufacturer of the product complies with GMP and that they are inspected regularly by the national health authorities. The World Health Organization (WHO) has set up a standard format for this type of certificate and recommends that this format is used instead of the Free Sale Certificates. A CPP (WHO format) generally covers the need for overall documentation regarding the product as well as the manufacturer. It should therefore not be necessary to request any of the certificates mentioned above. The certificate is also called a WHO certificate.

 

 

	What is a Certificate of Analysis?
	A certificate issued by the manufacturer for every batch of a product stating the specifications and actual test results of each parameter of the monograph. The certificate should be issued and signed by the manufacturer of the product (according to the product label) and not by the supplier/wholesaler.

 

 

	What is a Certificate of Origin?
	A certificate stating the origin of the product, i.e. the country in which the product has been manufactured. The certificate is issued by the manufacturer or the supplier and is stamped by the local Chamber of Commerce.

 

 

FDA Approves First Generic Pravastatin

The Food and Drug Administration today approved the first generic version of Bristol-Myers Squibb's Pravachol (Pravastatin Sodium Tablets), an important step in the agency's effort to increase the availability of lower-cost generic medications.

Pravastatin is indicated for the treatment of individuals with high cholesterol levels (hyperlipidemia) or who are at increased risk for atherosclerosis-related cardiac and cardiovascular events, such as heart attack and stroke in which high cholesterol levels are a factor. In 2005, Pravachol was the 22nd highest-selling brand-name drug in the United States, with sales totaling $1.3 billion.

"This approval is another example of our agency's endeavor to counter rising health care costs by approving safe and effective generic alternatives as soon as the law permits," said Dr. Scott Gottlieb, Deputy Commissioner for Medical and Scientific Affairs. "Pravastatin is a widely-used cholesterol-lowering agent, and its generic version can bring significant savings to the millions of Americans with this disease."

Generic drug products are used to fill over 50 percent of all prescriptions and since they cost a fraction of the price of brand name drugs, the economic impact of FDA's generic drug program is profound. With this in mind, the Office of Generic Drugs (OGD) continues working expeditiously to review and take action on generic drug applications as quickly as possibly. In addition there are several process improvements underway at the Agency to facilitate in the review of generic drug applications.

Among other initiatives, OGD is considering several simple, yet innovative new policies that could lead to the overall reduction of review time. These include new review formats which allow for overall risk assessments for individual applications in order to dictate the level of OGD review need for subsequent product changes. When fully implemented this has the potential to reduce supplements by 80 percent and reduce Office expenditures of time and money.

The Bristol-Myers Squibb's patent for the drug expired on April 20. Pravastatin Sodium Tablets (10mg, 20mg and 40mg) are manufactured by TEVA Pharmaceuticals in Kfar Sava, Israel.

FDA ANDA Checklist

這是學名藥客戶在美要file 的ANDA檢核表
FDA ANDA Checklist <-可下載word檔

和API supplier比較有關的如下:

Module 1 Administrative
1.3.5.2 patent certification
Paragraph IV is listed here

1.4.1 LOA
TYPE II DMF authorization

1.12.12 Comparison with RLD
2. active ingredients

Module 2 Summary
2.3.S
Drug Substance (Active Pharmaceutical Ingredient)
2.3.S.1
General Information
2.3.S.2
Manufacture
2.3.S.3
Characterization
2.3.S.4
Control of Drug Substance
2.3.S.5
Reference Standards or Materials
2.3.S.6
Container Closure System
2.3.S.7 Stability

Module 3 (其中3.2.s 全部都重要)
Manufacturer
3.2.S.2.1
Manufacturer(s) (This section includes contract manufacturers and testing labs)
Drug Substance (Active Pharmaceutical Ingredient)
1. Name and Full Address(es)of the Facility(ies)
2. Function or Responsibility
3. Type II DMF number for API
4. CFN or FEI numbers

The Purpose

The purpose of this Blog is to collect useful database, insight, strategy (finance, business, patent and regulation) that related to API business in regulated markets. Based in Taiwan, this blog contains English, Chinese and Japanese information. Welcome to subscribe our news by email or see hotest news at Twitter!

Ps. This is an English+Asian language blog and the target is to add English “abstract (subject or topic in English)” in >70% of the entries. Most of the articles/Slides are NOT written by me but I did some translation to try to serve more readers though my mother language is Mandarin. Likewise, I would put “Chinese subject” on English news about India (Ranbaxy, Dr Reddy’s lab..) but not able to translate all content into Chinese. I know this is obviously far from satisfactory or effective to English readers but I can do my best to help the readers who need specific tranlation in my blog upon request.

$24.7 Billion in Generic Savings Available This Year

Press Release
Source: Express Scripts, Inc.

$24.7 Billion in Generic Savings Available This YearTuesday June 6, 12:01 am ET
Driven by Blockbuster Brands Going Generic

ST. LOUIS, June 6 /PRNewswire/ -- Generic drugs could save U.S. consumers $24.7 billion this year alone, according to a report issued today by Express Scripts, one of the nation's largest managers of pharmacy benefit plans.
The report examined the clinical potential for greater generic drug use in six major drug-therapy classes used to treat common conditions like stomach ulcers, inflammation, depression, high blood pressure and high cholesterol. It was based on a random sample of approximately three million individuals projectable to the U.S. commercially insured population.
The $24.7 billion savings potential reflects the introduction this year of new generic drugs in two of the most widely-used classes -- the anti- cholesterol drug simvastatin (generic Zocor®) and the anti-depressant drug sertraline (generic Zoloft®). In 2005, Zocor® and Zoloft® had sales of $3.1 and $2.6 billion, respectively.
Thus, the biggest savings available this year are in the anti-cholesterol class at $10.3 billion. Generics, including lovastatin, pravastatin and ultimately simvastatin, are potent enough to fill 85 percent of all prescriptions for an anti-cholesterol drug, based on existing prescribing patterns.
On average, only 18.8 percent of anti-cholesterol prescriptions are currently filled with a generic. However, some health plans have already achieved generic utilization in the anti-cholesterol class exceeding 75 percent, according to published reports.
Potential generic drug savings across six drug therapy classes
2006 Generic
Drug Therapy Class Current Usage Potential Savings
Rate Targets if Generics Usage
(%) (%) Targets Reached
Anti-cholesterol 18.8 85 $10.3 billion
Gastrointestinals 35.4 95 $6.8 billion
Anti-depressant 57.0 85 $3.4 billion
Anti-hypertensives 58.3 75 $2.1 billion
NSAIDs 77.0 97 $1.2 billion
Calcium channel blockers 49.4 95 $0.9 billion
TOTAL POTENTIAL SAVINGS $24.7 billion
"We have a tremendous opportunity to conserve precious health care dollars by increasing our use of less expensive generic drugs and still achieve the same clinical benefit," said Dr. Ed Weisbart, Express Scripts chief medical officer.
The generic fill rate goals utilized in the report are based on an evaluation of clinical efficacy and market dynamics of branded and generic medications. In 2004 and 2005, failure to take advantage of the full potential of generic drugs in the six classes resulted in missed savings opportunities of $20 and $21.3 billion, respectively.
The Express Scripts report also ranked 2005 generic drug use and savings opportunities by state, revealing significant variations across the six drug categories.
Last year, California had the biggest absolute savings potential at $1.7 billion, but, on a per capita basis, Kentucky passed up the most savings at $163 per commercially insured life. New Mexico was best at capturing generic savings, leaving only $81 per capita unclaimed.
Using 2005 data as a guide, the states with the most to gain from greater use of generic anti-cholesterol drugs this year are Delaware, Michigan, West Virginia, Maryland, and Kentucky on a per capita basis. The leaders in absolute savings potential are California, Texas, Florida, Pennsylvania and Ohio.
In 2005, New Mexico and Massachusetts had the highest overall use of generic drugs at 60 and 59 percent, respectively, while New Jersey at 45 percent had the lowest. In addition to New Jersey, five other states had generic fill rates of less than 50 percent: Florida, Louisiana, Maryland, New York and Texas. Neither Hawaii nor Alaska was included in the analysis.
The savings opportunity from increased use of generic drugs has never been greater. More than $50 billion worth of branded drugs will lose patent exclusivity over the next five years. This year alone, $14.3 billion in drug sales are expected to lose patent, with generic alternatives becoming available for at least 16 branded drugs.
A generic drug costs approximately 60 percent less than a brand name drug, on average. Consumers also pay a lower co-payment for generic medications, saving $15 or more per prescription on average compared to branded medications.
Weisbart outlined four steps consumers, health plans, health professionals and policymakers can take to increase the use of generic drugs:
-- Increase awareness of the wide number of generic alternatives to brand
drugs.
-- Always assess if a generic drug would meet the clinical need; only
consider using a brand drug when there is clear evidence that the
brand drug provides an important clinical value not available with
today's generic medications. This strategy would free up resources to
meet other pressing health care needs and help preserve the pharmacy
benefit as we know it -- without impacting quality.
-- Adopt pharmacy benefit plan designs that encourage greater use of
generic drugs and share the savings with patients. For example, use
programs that provide for trying a generic drug before a brand.
Express Scripts recently announced that 14 million members of pharmacy
plans it manages are in such programs, a five-fold increase over 2.8
million in 2001.
-- Enact state laws and regulations that support the use of chemically
equivalent generic alternatives to brand drugs.
A copy of the report, with complete rankings for 48 states, will be available at http://www.expressscripts.com/ourcompany/news/outcomesresearch/onlinepublicati ons/ .
Express Scripts, Inc. (Nasdaq: ESRX - News) is one of the largest pharmacy benefit management (PBM) companies in North America, providing PBM services to over 55 million patients through facilities in 13 states and Canada. Express Scripts serves thousands of client groups, including managed-care organizations, insurance carriers, third-party administrators, employers and union-sponsored benefit plans. The Company also provides distribution services for specialty pharmaceuticals through its CuraScript specialty pharmacy. More information can be found at http://www.express-scripts.com .
Media Contact: Steve Littlejohn

Astellas Announces Application for the Immunosuppressant FK506 Modified Release Formulation in Japan

Tokyo, Japan, May 30, 2006 - (JCN Newswire) - Astellas Pharma Inc. (TSE: 4503) today announced that it has submitted an application for the market authorization for the immunosuppressant FK506 Modified Release Formulation (generic name: tacrolimus) to the Pharmaceuticals and Medical Devices Agency (PMDA) with the proposed indication of "suppression of organ rejection in organ transplantation" and "suppression of graft rejection and GVHD in bone marrow transplantation" on May 29, 2006 in Japan.Tacrolimus is an immunosuppressant discovered and developed by Astellas and is marketed as an immunosuppressant for organ transplantation under the brand name Prograf(R) in more than 70 countries. Since FK506 Modified Release Formulation is a once-daily oral formulation of tacrolimus, patients' compliance is expected to be improved compared to twice a day with the conventional formulation. The FK506 modified release formulation is therefore expected long term graft protective effect. In addition, this formulation is expected to be at least as safe as the conventional formulation since peak blood concentrations can be controlled at lower or even levels.As far as FK506 Modified Release Formulation is concerned, Astellas submitted a New Drug Application (NDA) in the US and a Marketing Authorization Application (MAA) in Europe, respectively, prior to the Japanese application.
About Astellas Pharma Inc.Astellas Pharma Inc., located in Tokyo, Japan, is a pharmaceutical company dedicated to improving the health of people around the world through the provision of innovative and reliable pharmaceutical products. In April 2005, the company was formed through the merger of Fujisawa Pharmaceutical Co., Ltd. and Yamanouchi Pharmaceutical Co., Ltd. The organization is committed to becoming a global mega pharmaceutical company by combining outstanding R&D and marketing capabilities and continuing to grow in the world pharmaceutical market. For more information on Astellas Pharma Inc., please visit the company's website at www.astellas.com. Contact: Astellas Pharma Inc.
Corporate Communications
Tel: +81-3-3244-3201
Fax: +81-3-5201-7473
email: http://www.astellas.com

默沙東的研發及授權

請連結到powerpoint檔

Pravochol generics arrive

26th April 2006
By Helen Marshall

Under a distribution agreement with Bristol-Myers Squibb, Watson Pharmaceuticals has initiated shipments of pravastatin sodium tablets, its generic version of the heart drug Pravochol. Meanwhile, Teva Pharmaceuticals has gained FDA approval to sell its own generic version of the drug.
Watson's pravastatin sodium product is the authorized generic version of Bristol-Myers Squibb's Pravachol and is indicated along with diet to reduce the risk of both first heart attack in patients with elevated cholesterol and recurrent heart attack or a stroke in patients with heart disease, when diet and exercise are not enough.
In 2005, Pravachol was the 22nd highest-selling brand-name drug in the US, with sales totaling $1.3 billion. Bristol-Myers Squibb's patent for the drug expired on April 20, 2006.
Watson's announcement came just a day after the FDA approved the first generic version of Pravachol, which will be manufactured and marketed by Israeli generics heavyweight Teva Pharmaceuticals.
In addition to announcing the Teva approval, the FDA also reported that the Office of Generic Drugs (OGD) is continuing with work to review and take action on generic drug applications as quickly as possibly.
There are several process improvements underway at the FDA to facilitate in the review of generic drug applications. Among other things, the OGD is considering several simple, yet innovative new policies that could lead to the overall reduction of review time. These include new review formats that allow for overall risk assessments for individual applications in order to dictate the level of OGD review need for subsequent product changes.

Malta employs patent quirk to cash in on copycat drugs: The Mediterranean island has become the generics industry's new home

By FT.com / September 19, 2005 02:44 AM

In a chilled low-pressure room that contrasts sharply with the humid Maltese weather outside, a poster reminds the white-coated staff of Actavis that they have just six weeks to finish work on a new drug.
Every day counts as the 320 employees of the generic-drugs manufacturer finalise their latest launch, exploiting an anomaly with patents that is turning the tiny Mediterranean island into an unexpected investment location for the pharmaceutical industry.
"Malta will be the powerhouse for western Europe for our production and increasingly for the development of new products," says Robert Wessman, chief executive of Actavis.
His staff are gearing up for the end of October, when they will begin to ship across Europe large volumes of sertraline, a low-cost copy of Pfizer's antidepressant Zoloft, which they are authorised to sell on the first day after the patent expires.
Actavis has its headquarters on the far side of Europe, in Iceland. But while the climates of the two islands could not be more different, they have one thing in common: for a long time they have both operated without heavy patent restrictions .
Nearly a thousand years after the Knights Hospitaller established their centre in Malta to treat the wounded of the Crusades, that latitude is again helping the country become a centre for medicine and health.
"Pharmaceuticals is becoming a very important sector and can help transform us into a knowledge economy," says Tonio Fenech, parliamentary secretary at Malta's ministry of finance.
To date, it has approved inward investment packages to lure 20 small human and veterinary pharmaceutical businesses and is in discussions with another six. Malta recently hosted an international conference on generics, and is awaiting visits from two Indian companies.
The key allure is the island's modest size. Malta, which was under British control until 1964, has strong intellectual property protection laws. But given its population of just 400,000, few pharmaceutical companies bothered to incur the costs of registering local patents.
Malta also interprets the so-called Bolar provision in a way that is generous to the generics industry. The Bolar provision allows competitors to start developing copycat products six years after a pharmaceutical company first applies for authorisation to market a new drug, even while the drug is is still patent-protected.
No such rival drug based on the same chemical composition can be launched until the patent expires. But the extra three to four years' lead time gives an edge in the low-margin, highly competitive generic industry sector. The first into the market often wins and keeps the greatest share.
"Without this patent situation in Malta, we could not do development, up-scaling, validation or stockpiling in Europe," says Mr Wessman, who acquired the local factory in 2001.
The previous owner - a Netherlands-based international group - sold generics to developing countries, but was increasingly squeezed by undercutting from lower-cost Indian generics companies, and rising European regulatory standards.
Mr Wessman recognised the need to diversify Actavis' activities outside Iceland, and says Malta's employees cost less than half as much, were flexible and spoke English. The island also offered soft loans, generous tax breaks and subsidised office space.
Steinthor Palsson, who runs the company's Malta factory, adds that the island's small size means it is easy to contact senior government officials directly. "The lines of communication are short," he says. "That's very handy when you want to impress a visitor."
Joseph Tabona, chairman of Malta Enterprise, the local inward investment agency, concedes that the current favourable conditions will not last forever.
The leading drugs companies have now begun registering their patents in Malta, although they cannot do so retrospectively. There is also pressure to tighten the Bolar provision across Europe. The even lower costs of the rising number of Indian generics companies are posing a fresh challenge.
"We have a window of opportunity for 15 years," says Mr Tabona. "We view generics as a stepping stone to other things such as 'health tourism' as we construct a new hospital."
Philip Micallef, managing director of the local operations of Amino Chemicals, a manufacturer of the "active pharmaceutical ingredients" used in medicines, says he is very happy in Malta. "We can develop and register products here and start selling them midnight of the expiry date of the patent."
But if the island's size has helped win it a temporary advantage it also brings problems. He says the arrival of new companies is putting pressure on the infrastructure, and has already led to rivals poaching the relatively small number of qualified personnel.
"For the country, more pharmaceutical companies helps, but to be honest, for us, the fewer competitors the better," he says.

ANDREW JACK
(C) Copyright The Financial Times Limited 2005. 'FT' and 'Financial Times' are trademarks of The Financial Times.

生物仿制藥物(biogenerics)在美遇阻

本報記者 聶翠蓉

　　仿制生物藥物的技術難題
　　生物仿制藥要想上市，必須解決兩大難題，第一就是如何證明仿制藥與原始藥物的化學結構和治療效果一致。像阿司匹林等傳統藥物，都是結構簡單的小分子，生產商們可以直接在實驗室合成并用化學方法分析其純度和藥效，美國食品和藥物管理局在審批時，只需30個病人參與的臨床試驗數據即可，因而上市后的藥價非常便宜，廠商能很快獲得利潤。但生物技術類藥物卻完全不同，它們是結構復雜的大分子—蛋白質，其生產方式也與傳統的化工技術不同，一般采用轉基因細菌或細胞作為生產工廠。這種活細胞生產技術要求非常精確，只要溫度或純度發生少許改變，就會出現意想不到的結果，導致藥效降低甚至出現嚴重的副作用。生物技術類藥物的鑒別不是通過化學結構，而是通過特殊的生產工藝，美國食品和藥物管理局不僅需要審批最終的生物技術產品，還要審批生產工藝。而生產工藝往往被大公司作為商業秘密進行封鎖，仿制公司很難獲得。另外，即使是仿制藥，美國生物技術聯盟也要求像新藥品一樣進行臨床試驗，這無疑增加了仿制藥的成本。
　　目前能精確識別蛋白質特征的新技術有助于將生物技術產品從復雜的生產工藝中解放出來，并降低臨床試驗的成本，比如以色利和英國的生物技術公司利用特殊的分析技術和計算方法能精確獲得蛋白質的三維結構，可以確定哪些部分對蛋白質的藥效、■能和副作用產生作用。而另外一些仿制公司開發出的新技術還能觀察到蛋白質發生變化的另一原因：他們發現在活細胞生產蛋白質的過程中，經常有些糖類分子會在■的作用下與蛋白質結合，隨著細胞生長條件的變化，■的作用也會改變，從而給出不同指令，導致與蛋白質結合的糖分子數目和種類不同。有些公司利用■技術、傳統的分析技術和特有的計算機算法，可以精確地描繪出糖分子的結構。有的公司利用與分析基因順序或基因活性的基因芯片相似的糖類檢測矩陣技術分析蛋白質中的糖類組分。既然從技術的角度完全可以模擬生物藥物的結構，仿制還有什么障礙呢?
　　仿制生物藥物的體制障礙
　　由于美國仿制藥相關法律是上世紀80年代通過的，只適用于小分子藥物的仿制，復雜的生物類藥物沒有在法律考慮的範圍之內，生物仿制藥缺乏相應的法律依據，這是阻礙生物仿制藥上市的另一因素。
　　2003年，為了推動病人早日得到生物仿制藥，美國食品和藥物管理局計劃出臺如何審批生物仿制藥的指導綱要，但是直到現在還沒有結果。有消息稱，這一草擬的指導綱要只適用于人類生長激素和胰島素等相對簡單的蛋白質分子。有參議院甚至提議不要把問題考慮得過于復雜，只要將現有的仿制藥法律適用範圍擴充，覆蓋所有的蛋白質藥物即可。今年6月，美國參議院司法委員會也舉行了聽證會，希望在2005年能出臺涵蓋生物類藥物的仿制藥審批法律。
　　美國一些大的生物制藥公司極力反對相關法律的出臺，它們認為仿制藥會大大降低自己的收入，而這些收入是繼續開發新型高成本生物技術藥物的保障。事實上，傳統小分子藥物的情況證明，仿制藥并不會減緩創新的步伐。在同類藥物的競爭壓力下，生物公司會不斷對藥物進行改進，比如提高藥物作用時間，來維持市場份額，促進整個生物藥物產業的提升。
　　另外，靠生物技術類藥物賺了大錢的公司認為，生物技術類藥物的生產過程過于復雜，復制起來相當困難。稍有疏忽，仿制公司花巨資生產的同類藥可能沒有藥效甚至會出現副作用而傷害病人。但一些專家也表示，大生物技術公司之所以擺出如此姿態，只是不想失去生物藥物的大蛋糕。
　　仿制公司表示，傳統的化學藥物仿制后藥價會降低50%這樣大的幅度，但生物技術仿制藥不會有這么大的價格下降空間。生物仿制藥在得到美國食品和藥物管理局審批通過前，必須進行嚴格的臨床試驗，另外，大多數生物技術類藥物不允許在藥店銷售，必須在醫生的指導下使用，仿制公司必須拿出一定的費用讓醫生們相信這些仿制藥的安全性和藥效，這無疑又是一筆不小的負擔。專家們表示，只有少數生物技術類藥物的價格會下降50%%到40%，大多數只能下降10%到20%。對于每年數萬美元的消費者來說，10%的價格下降也具有重要的意義。
　　仿制生物藥物前景無限好
　　雖然有專家預言，生物技術同類藥的上市還需要5年時間，但那些需要生物藥物的病人們仍然對此寄予很大的希望。
　　隨著生物技術藥物價格的不斷上漲和更多的專利藥物過期，病人、醫保機構和生物仿制藥生產商開始不斷施加壓力，希望改變生物技術仿制藥的窘境。據統計，美國醫保機構每年僅用于紅細胞生成素（治療癌症病人和腎衰病人貧血症狀的蛋白）就有10億美元，1998年—2003年間，生物藥物的花費增加了3倍多，到2005年底，這一數字可能再翻一倍。人們已經無法承受，許多病人甚至面臨家庭破產。而仿制藥生產商們表示，他們已經擁有了精確仿制的新技術。目前，在拉丁美洲和歐洲生物仿制藥物已經上市多年。

科技日報全文網址
http://61.135.129.207/big5/misc/2004-12/09/content_333334.htm