Commentaries & Analyses — Strategic Balancing Of Patent And FDA Approval Processes To Maximize Market Exclusivity

2003 ◽  
Vol 07 (16) ◽  
pp. 997-1005
Author(s):  
DENNIS S. FERNANDEZ ◽  
JAMES T. HUIE
Keyword(s):  
Research And Development ◽  
Drug Administration ◽  
Generic Drug ◽  
Market Entry ◽  
Market Exclusivity ◽  
Federal Drug Administration ◽  
Biotech Company ◽  
Company Value ◽  
Drug Companies ◽  
Fda Approval

The patentability of products is essential in the biotechnology field, for limited market exclusivity compensates biotech companies' investments in research and development. The biotechnology field also uniquely faces Federal Drug Administration (FDA) approval, which includes considerable additional expense and time issues a biotech company must address. Although balancing the patent and FDA approval processes may be complex, various strategies of patent extension, of accelerating approval processes, and of prolonging generic drug companies' market entry can yield higher profit returns and maximize value company value.

AIDS Drugs & the Pharmaceutical Industry: A Need For Reform

1991 ◽  
Vol 17 (4) ◽  
pp. 363-410
Author(s):  
Mary T. Griffin
Keyword(s):  
Pharmaceutical Industry ◽  
Research And Development ◽  
Drug Approval ◽  
Hiv And Aids ◽  
Price Regulation ◽  
Drug Industry ◽  
Drug Companies ◽  
Aids Drugs

AbstractThe pharmaceutical industry has long enjoyed substantial profits despite increased requirements for drug approval and various attempts to regulate the industry. Drug companies have avoided effective regulation by blaming high prices on the costs of research and development. The search for drugs effective in combatting HIV and AIDS related illnesses has provided a stark background on which to view the actions and justifications of drug companies. Despite increased cooperation between government and the drug industry and expedited approval of several useful drugs, these drugs are still prohibitively expensive. This Article explores the history and economics of the drug industry and proposes a system of national price regulation for all drugs.

WHAT A SURPRISE!

PEDIATRICS ◽  
1994 ◽  
Vol 94 (5) ◽  
pp. 747-747
Keyword(s):  
Research And Development ◽  
Senate Committee ◽  
Drug Companies

Drug companies ... claim that they price drugs as they do to compensate for huge investments in research and development. But the Senate Committee on Aging said in a report that more money is spent on marketing drugs than developing them.

The generic drug market in Japan: will it finally take off?

2010 ◽  
Vol 6 (3) ◽  
pp. 369-389 ◽  
Author(s):  
Toshiaki Iizuka ◽  
Kensuke Kubo
Keyword(s):  
Health Care ◽  
Generic Drug ◽  
Generic Substitution ◽  
Drug Market ◽  
Government Policies ◽  
Brand Name ◽  
Market Exclusivity ◽  
Market Participants ◽  
The Government ◽  
Generic Usage

AbstractHistorically, brand-name pharmaceuticals have enjoyed long periods of market exclusivity in Japan, given the limited use of generics after patent expiration. To improve the efficiency of the health-care system, however, the government has recently implemented various policies aimed at increasing generic substitution. Although this has created expectations that the Japanese generic drug market may finally take off, to date, generic usage has increased only modestly. After reviewing the incentives of key market participants to choose generics, we argue that previous government policies did not provide proper incentives for pharmacies to boost generic substitution. We offer some recommendations that may help to increase generic usage.

Biosimilar epoetin for cancer and chemotherapy-induced anaemia in the US

2021 ◽  
Vol 10 (3) ◽  
pp. 122-122
Author(s):  
Charles L Bennett
Keyword(s):  
Advisory Committee ◽  
Drug Administration ◽  
Food And Drug Administration ◽  
Pharmacokinetics And Pharmacodynamics ◽  
Safety And Efficacy ◽  
Biological Drug ◽  
Drug Products ◽  
Fda Approval ◽  
The Us ◽  
Approval Letter

Biosimilars are biological drug products that are highly similar to reference products in analytic features, pharmacokinetics and pharmacodynamics, immunogenicity, safety and efficacy. Biosimilar epoetin received US Food and Drug Administration (FDA) approval in 2018 [1]. The manufacturer received an FDA non-approval letter in 2017, despite receiving a favourable review by the FDA’s Oncologic Drugs Advisory Committee (ODAC) and an FDA non-approval letter in 2015 for an earlier formulation.

Ibuprofen for Fever

PEDIATRICS ◽  
1991 ◽  
Vol 87 (1) ◽  
pp. 125-126
Author(s):  
MARTIN I. LORIN
Keyword(s):  
Metabolic Acidosis ◽  
Young Children ◽  
Aseptic Meningitis ◽  
Drug Administration ◽  
Federal Drug Administration ◽  
Liquid Preparation ◽  
Infants And Young Children

To the Editor.— I am writing to voice concern about the use of ibuprofen for simple antipyresis in infants and young children. Although there have been enough data about the new liquid preparation to convince the Federal Drug Administration to release it, it must be recognized that the total number of infants and young children reported who have received this drug is far from massive. Recognition of aseptic meningitis as a complication of ibuprofen therapy1,2 and reports of metabolic acidosis as a complication of overdosage3 are both relatively recent events.

Efficacy, Safety, and Regulatory Approval of Food and Drug Administration–Designated Breakthrough and Nonbreakthrough Cancer Medicines

2018 ◽  
Vol 36 (18) ◽  
pp. 1805-1812 ◽  
Author(s):  
Thomas J. Hwang ◽  
Jessica M. Franklin ◽  
Christopher T. Chen ◽  
Julie C. Lauffenburger ◽  
Bishal Gyawali ◽  
...  
Keyword(s):  
Adverse Events ◽  
Solid Tumors ◽  
Drug Administration ◽  
Mechanism Of Action ◽  
Food And Drug Administration ◽  
Progression Free Survival ◽  
Cancer Drugs ◽  
Serious Adverse Events ◽  
Hazard Ratios ◽  
Fda Approval

Purpose The breakthrough therapy program was established in 2012 to expedite the development and review of new medicines. We evaluated the times to approval, efficacy, and safety of breakthrough-designated versus non–breakthrough-designated cancer drugs approved by the US Food and Drug Administration (FDA). Methods We studied all new cancer drugs approved by the FDA between January 2012 and December 2017. Regulatory and therapeutic characteristics (time to FDA approval, pivotal trial efficacy end point, novelty of mechanism of action) were compared between breakthrough-designated and non–breakthrough-designated cancer drugs. Random-effects meta-regression was used to assess the association between breakthrough therapy designation and hazard ratios for progression-free survival (PFS), response rates (RRs) for solid tumors, serious adverse events, and deaths not attributed to disease progression. Results Between 2012 and 2017, the FDA approved 58 new cancer drugs, 25 (43%) of which received breakthrough therapy designation. The median time to first FDA approval was 5.2 years for breakthrough-designated drugs versus 7.1 years for non–breakthrough-designated drugs (difference, 1.9 years; P = .01). There were no statistically significant differences between breakthrough-designated and non–breakthrough-designated drugs in median PFS gains (8.6 v 4.0 months; P = .11), hazard ratios for PFS (0.43 v 0.51; P = .28), or RRs for solid tumors (37% v 39%; P = .74). Breakthrough therapy–designated drugs were not more likely to act via a novel mechanism of action (36% v 39%; P = 1.00). Rates of deaths (6% v 4%; P = .99) and serious adverse events (38% v 36%; P = 0.93) were also similar in breakthrough-designated and non–breakthrough-designated drugs. Conclusion Breakthrough-designated cancer drugs were associated with faster times to approval, but there was no evidence that these drugs provide improvements in safety or novelty; nor was there a statistically significant efficacy advantage when compared with non–breakthrough-designated drugs.

Industry Watch

2003 ◽  
Vol 07 (22) ◽  
pp. 1391-1406
Keyword(s):  
Drug Discovery ◽  
Animal Health ◽  
Biotech Company ◽  
Discovery Research ◽  
Fda Approval ◽  
Drug Discovery Research ◽  
Medical Facilities ◽  
Us Government ◽  
Health Products ◽  
Us Fda

Alliance between AGT Biosciences and Starpharma. First Australian Biotech Company to List on HKSE. Breakthrough in Transdermal Drug Discovery Technology. Acrux Licenses MDTS Technology to Eli Lilly got Animal Health Products. Biota Secures SARS Testing Agreement with US Government Research Agencies. SysArris in Bio Partnering Europe 2003. Shantha Bio to Launch Streptokinase by Year-end. Lupin Receives US FDA Approval to Launch Ceftriaxone. MerLion Pharma Collaborates with Schering-Plough in Drug Discovery Research. Quest Pharmaceutical Sets up Taiwanese Subsidiary. BenQ to Invest in Nanjing's Medical Facilities.

Therapeutic Equivalence and the Generic Competition Paradox

2012 ◽  
Vol 12 (1) ◽  
Author(s):  
Munirul Haque Nabin ◽  
Vijay Mohan ◽  
Aaron Nicholas ◽  
Pasquale M. Sgro
Keyword(s):  
Simple Model ◽  
Generic Drug ◽  
Generic Drugs ◽  
Large Body ◽  
Medical Community ◽  
Therapeutic Equivalence ◽  
Generic Competition ◽  
Branded Drug ◽  
Fda Approval ◽  
Generic Products

Abstract Following the passage of the Waxman-Hatch Act (1984), FDA approval for a generic drug requires the establishment of bio-equivalence between the generic drug and an FDA approved branded drug. However, a large body of evidence in the medical community suggests that bio-equivalence does not guarantee therapeutic equivalence; in some instances the lack of therapeutic equivalence can lead to fatal consequences for patients switching to generic products. In this paper, we construct a simple model to analyze the implications of therapeutic non-equivalence between branded and generic drugs. We show, theoretically and empirically, that this distinction can provide a plausible explanation of the generic competition paradox.

Sign in / Sign up

Export Citation Format

Share Document