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44-531: Terminology surrounding biopharmaceuticals varies between groups and entities, with different terms referring to different subsets of therapeutics within the general biopharmaceutical category. Some regulatory agencies use the terms biological medicinal products or therapeutic biological product to refer specifically to engineered macromolecular products like protein- and nucleic acid -based drugs , distinguishing them from products like blood, blood components, or vaccines, which are usually extracted directly from

88-399: A license to operate from the sector regulator. This license will set out the conditions by which the companies or organizations operating within the industry must abide. Regulatory regimes vary by country and industry. In the most light-touch forms of regulation, regulatory agencies are typically charged with overseeing a defined industry. Usually they will have two general tasks: In

132-506: A virus to include a desirable piece of genetic material. Viral gene therapies using engineered plant viruses have been proposed to enhance crop performance and promote sustainable production. With the expiration of many patents for blockbuster biologics between 2012 and 2019, the interest in biosimilar production, i.e., follow-on biologics, has increased. Compared to small molecules that consist of chemically identical active ingredients , biologics are vastly more complex and consist of

176-420: A DBA must be registered with a local or state government, or both, depending on the jurisdiction. For example, California, Texas and Virginia require a DBA to be registered with each county (or independent city in the case of Virginia) where the owner does business. Maryland and Colorado have DBAs registered with a state agency. Virginia also requires corporations and LLCs to file a copy of their registration with

220-467: A DBA statement, though names including the first and last name of the owner may be accepted. This also reduces the possibility of two local businesses operating under the same name, although some jurisdictions do not provide exclusivity for a name, or may allow more than one party to register the same name. Note, though, that this is not a substitute for filing a trademark application. A DBA filing carries no legal weight in establishing trademark rights. In

264-654: A biological source. Biopharmaceutics is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. Specialty drugs , a recent classification of pharmaceuticals, are high-cost drugs that are often biologics. The European Medicines Agency uses the term advanced therapy medicinal products (ATMPs) for medicines for human use that are "based on genes, cells, or tissue engineering", including gene therapy medicines, somatic-cell therapy medicines, tissue-engineered medicines, and combinations thereof. Within EMA contexts,

308-516: A businessperson writes a trade name on a contract, invoice, or cheque, they must also add the legal name of the business. Numbered companies will very often operate as something other than their legal name, which is unrecognizable to the public. In Chile , a trade name is known as a nombre de fantasía ('fantasy' or 'fiction' name), and the legal name of business is called a razón social (social name). In Ireland , businesses are legally required to register business names where these differ from

352-470: A multitude of subspecies. Due to their heterogeneity and the high process sensitivity, originators and follow-on biosimilars will exhibit variability in specific variants over time. The safety and clinical performance of both originator and biosimilar biopharmaceuticals must remain equivalent throughout their lifecycle. Process variations are monitored by modern analytical tools (e.g., liquid chromatography , immunoassays , mass spectrometry , etc.) and describe

396-467: A part of the executive branch of the government and have statutory authority to perform their functions with oversight from the legislative branch. Their actions are often open to legal review . However, some regulatory bodies are industry-led initiatives rather than statutory agencies, and are called 'voluntary organisations'. They may be not-for-profit organisations or limited companies. They derive their authority from members' commitments to abide by

440-458: A registered legal name and a fictitious business name, or trade name, is important because fictitious business names do not always identify the entity that is legally responsible . Legal agreements (such as contracts ) are normally made using the registered legal name of the business. If a corporation fails to consistently adhere to such important legal formalities like using its registered legal name in contracts, it may be subject to piercing of

484-531: A relevant government body is often required. In a number of countries, the phrase " trading as " (abbreviated to t/a ) is used to designate a trade name. In the United States , the phrase " doing business as " (abbreviated to DBA , dba , d.b.a. , or d/b/a ) is used, among others, such as assumed business name or fictitious business name . In Canada , " operating as " (abbreviated to o/a ) and " trading as " are used, although " doing business as "

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528-1121: A supply shortage for these products. Institutions housing these biologics, designated as 'banks', often cannot distribute their product to customers effectively. Conversely, banks for reproductive cells are much more widespread and available due to the ease with which spermatozoa and egg cells can be used for fertility treatment. Biopharmaceuticals may be produced from microbial cells (e.g., recombinant E. coli or yeast cultures), mammalian cell lines (see Cell culture ) and plant cell cultures (see Plant tissue culture ) and moss plants in bioreactors of various configurations, including photo-bioreactors . Important issues of concern are cost of production (low-volume, high-purity products are desirable) and microbial contamination (by bacteria , viruses , mycoplasma ). Alternative platforms of production which are being tested include whole plants ( plant-made pharmaceuticals ). A potentially controversial method of producing biopharmaceuticals involves transgenic organisms, particularly plants and animals that have been genetically modified to produce drugs. This production

572-402: A unique design space for each biologic. Biosimilars require a different regulatory framework compared to small-molecule generics. Legislation in the 21st century has addressed this by recognizing an intermediate ground of testing for biosimilars. The filing pathway requires more testing than for small-molecule generics, but less testing than for registering completely new therapeutics. In 2003,

616-785: A wide range of biological products in medicine. However, in most cases, the term is used more restrictively for a class of therapeutics (either approved or in development) that are produced using biological processes involving recombinant DNA technology. These medications are usually one of three types: Biologics as a class of medications in this narrower sense have had a profound impact on many medical fields, primarily rheumatology and oncology , but also cardiology , dermatology , gastroenterology , neurology , and others. In most of these disciplines, biologics have added major therapeutic options for treating many diseases, including some for which no effective therapies were available, and others where previously existing therapies were inadequate. However,

660-766: Is a lack of effective competition . Examples of regulatory agencies that enforce standards include the Food and Drug Administration in the United States and the Medicines and Healthcare products Regulatory Agency in the United Kingdom ; and, in the case of economic regulation , the Office of Gas and Electricity Markets and the Telecom Regulatory Authority in India . Regulatory agencies may be

704-453: Is a significant risk for its investor due to production failure or scrutiny from regulatory bodies based on perceived risks and ethical issues. Biopharmaceutical crops also represent a risk of cross-contamination with non-engineered crops, or crops engineered for non-medical purposes. One potential approach to this technology is the creation of a transgenic mammal that can produce the biopharmaceutical in its milk, blood, or urine. Once an animal

748-454: Is also sometimes used. A company typically uses a trade name to conduct business using a simpler name rather than using their formal and often lengthier name. Trade names are also used when a preferred name cannot be registered, often because it may already be registered or is too similar to a name that is already registered. Using one or more fictitious business names does not create additional separate legal entities. The distinction between

792-611: Is produced, typically using the pronuclear microinjection method, it becomes efficacious to use cloning technology to create additional offspring that carry the favorable modified genome. The first such drug manufactured from the milk of a genetically modified goat was ATryn , but marketing permission was blocked by the European Medicines Agency in February 2006. This decision was reversed in June 2006 and approval

836-649: The European Medicines Agency introduced an adapted pathway for biosimilars, termed similar biological medicinal products . This pathway is based on a thorough demonstration of comparability of the product to an existing approved product. Within the United States, the Patient Protection and Affordable Care Act of 2010 created an abbreviated approval pathway for biological products shown to be biosimilar to, or interchangeable with, an FDA-licensed reference biological product. Researchers are optimistic that

880-403: The United Kingdom , there is no filing requirement for a "business name", defined as "any name under which someone carries on business" that, for a company or limited liability partnership, "is not its registered name", but there are requirements for disclosure of the owner's true name and some restrictions on the use of certain names. A minority of U.S. states, including Washington , still use

924-613: The Biologics and Genetic Therapies Directorate within Health Canada . Regulatory agency A regulatory agency ( regulatory body , regulator ) or independent agency ( independent regulatory agency ) is a government authority that is responsible for exercising autonomous dominion over some area of human activity in a licensing and regulating capacity. These are customarily set up to strengthen safety and standards, and/or to protect consumers in markets where there

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968-418: The U.S., trademark rights are acquired by use in commerce, but there can be substantial benefits to filing a trademark application. Sole proprietors are the most common users of DBAs. Sole proprietors are individual business owners who run their businesses themselves. Since most people in these circumstances use a business name other than their own name, it is often necessary for them to get DBAs. Generally,

1012-436: The advent of biologic therapeutics has also raised complex regulatory issues (see below), and significant pharmacoeconomic concerns because the cost for biologic therapies has been dramatically higher than for conventional (pharmacological) medications. This factor has been particularly relevant since many biological medications are used to treat chronic diseases , such as rheumatoid arthritis or inflammatory bowel disease, or for

1056-445: The benefit of the public at large). The existence of independent regulatory agencies is justified by the complexity of certain regulatory and directorial tasks, and the drawbacks of political interference. Some independent regulatory agencies perform investigations or audits , and other may fine the relevant parties and order certain measures. In a number of cases, in order for a company or organization to enter an industry, it must obtain

1100-562: The biopharmaceutical industry, generating 37 percent of the total number of granted patents worldwide; however, there is still a large margin for growth and innovation within the industry. Revisions to the current IP system to ensure greater reliability for R&D (research and development) investments is a prominent topic of debate in the US as well. Blood products and other human-derived biologics such as breast milk have highly regulated or very hard-to-access markets; therefore, customers generally face

1144-484: The corporate veil . In English , trade names are generally treated as proper nouns . In Argentina , a trade name is known as a nombre de fantasía ('fantasy' or 'fiction' name), and the legal name of business is called a razón social (social name). In Brazil , a trade name is known as a nome fantasia ('fantasy' or 'fiction' name), and the legal name of business is called razão social (social name). In some Canadian jurisdictions , such as Ontario , when

1188-534: The county or city to be registered with the State Corporation Commission. DBA statements are often used in conjunction with a franchise . The franchisee will have a legal name under which it may sue and be sued, but will conduct business under the franchiser's brand name (which the public would recognize). A typical real-world example can be found in a well-known pricing mistake case, Donovan v. RRL Corp. , 26 Cal. 4th 261 (2001), where

1232-474: The drug is released, it will still be monitored for performance and safety risks. The manufacture process must satisfy the FDA's "Good Manufacturing Practices", which are typically manufactured in a cleanroom environment with strict limits on the amount of airborne particles and other microbial contaminants that may alter the efficacy of the drug. In Canada , biologics (and radiopharmaceuticals) are reviewed through

1276-787: The event that the regulated company is not in compliance with its license obligations or the law, the regulatory agency may be empowered to: In some instances, it is deemed in the public interest (by the legislative branch of government) for regulatory agencies to be given powers in addition to the above. This more interventionist form of regulation is common in the provision of public utilities , which are subject to economic regulation . In this case, regulatory agencies have powers to: The functions of regulatory agencies in prolong "collaborative governance" provide for generally non-adversarial regulation. Ex post actions taken by regulatory agencies can be more adversarial and involve sanctions, influencing rulemaking , and creating quasi-common law. However,

1320-446: The introduction of biosimilars will reduce medical expenses to patients and the healthcare system. When a new biopharmaceutical is developed, the company will typically apply for a patent , which is a grant to exclusive manufacturing rights. This is the primary means by which the drug developer can recover the investment cost for development of the biopharmaceutical. The patent laws in the United States and Europe differ somewhat on

1364-402: The law is to protect the public from fraud, by compelling the business owner to first file or register his fictitious business name with the county clerk, and then making a further public record of it by publishing it in a newspaper. Several other states, such as Illinois , require print notices as well. In Uruguay , a trade name is known as a nombre fantasía , and the legal name of business

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1408-461: The named defendant, RRL Corporation, was a Lexus car dealership doing business as " Lexus of Westminster ", but remaining a separate legal entity from Lexus, a division of Toyota Motor Sales, USA, Inc. . In California , filing a DBA statement also requires that a notice of the fictitious name be published in local newspapers for some set period of time to inform the public of the owner's intent to operate under an assumed name . The intention of

1452-487: The production process and its control. For example: In the United States , biologics are licensed through the biologics license application (BLA), then submitted to and regulated by the FDA's Center for Biologics Evaluation and Research (CBER) whereas drugs are regulated by the Center for Drug Evaluation and Research . Approval may require several years of clinical trials , including trials with human volunteers. Even after

1496-462: The requirements for a patent, with the European requirements perceived as more difficult to satisfy. The total number of patents granted for biopharmaceuticals has risen significantly since the 1970s. In 1978 the total patents granted was 30. This had climbed to 15,600 in 1995, and by 2001 there were 34,527 patent applications. In 2012 the US had the highest IP (Intellectual Property) generation within

1540-407: The roles of regulatory agencies as "regulatory monitors" provide a vital function in administering law and ensuring compliance. Trade name A trade name , trading name , or business name is a pseudonym used by companies that do not operate under their registered company name. The term for this type of alternative name is fictitious business name . Registering the fictitious name with

1584-513: The standards applied by the regulator, for instance as the UK's Advertising Standards Authority says "The self-regulation system works because it is powered and driven by a sense of corporate social responsibility amongst the advertising industry." Regulatory agencies deal in the areas of administrative law , regulatory law , secondary legislation , and rulemaking (codifying and enforcing rules and regulations, and imposing supervision or oversight for

1628-459: The surname(s) of the sole trader or partners, or the legal name of a company. The Companies Registration Office publishes a searchable register of such business names. In Japan , the word yagō ( 屋号 ) is used. In Colonial Nigeria , certain tribes had members that used a variety of trading names to conduct business with the Europeans. Two examples were King Perekule VII of Bonny , who

1672-473: The term advanced therapies refers specifically to ATMPs, although that term is rather nonspecific outside those contexts. Gene-based and cellular biologics, for example, often are at the forefront of biomedicine and biomedical research , and may be used to treat a variety of medical conditions for which no other treatments are available. Building on the market approvals and sales of recombinant virus-based biopharmaceuticals for veterinary and human medicine,

1716-469: The term trade name to refer to "doing business as" (DBA) names. In most U.S. states now, however, DBAs are officially referred to using other terms. Almost half of the states, including New York and Oregon , use the terms assumed business name or assumed name ; nearly as many, including Pennsylvania , use the term fictitious name . For consumer protection purposes, many U.S. jurisdictions require businesses operating with fictitious names to file

1760-540: The treatment of otherwise untreatable cancer during the remainder of life. The cost of treatment with a typical monoclonal antibody therapy for relatively common indications is generally in the range of €7,000–14,000 per patient per year. Older patients who receive biologic therapy for diseases such as rheumatoid arthritis , psoriatic arthritis , or ankylosing spondylitis are at increased risk for life-threatening infection, adverse cardiovascular events, and malignancy . The first such substance approved for therapeutic use

1804-543: The use of engineered plant viruses has been proposed to enhance crop performance and promote sustainable production. In some jurisdictions, biologics are regulated via different pathways from other small molecule drugs and medical devices . Some of the oldest forms of biologics are extracted from the bodies of animals, and other humans especially. Important biologics include: Some biologics that were previously extracted from animals, such as insulin, are now more commonly produced by recombinant DNA . Biologics can refer to

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1848-594: Was biosynthetic "human" insulin made via recombinant DNA . Sometimes referred to as rHI, under the trade name Humulin , was developed by Genentech , but licensed to Eli Lilly and Company , who manufactured and marketed it starting in 1982. Major kinds of biopharmaceuticals include: Research and development investment in new medicines by the biopharmaceutical industry stood at $ 65.2 billion in 2008. A few examples of biologics made with recombinant DNA technology include: Many vaccines are grown in tissue cultures. Viral gene therapy involves artificially manipulating

1892-489: Was given August 2006. In the European Union , a biological medicinal product is one of the active substance(s) produced from or extracted from a biological (living) system, and requires, in addition to physicochemical testing, biological testing for full characterisation. The characterisation of a biological medicinal product is a combination of testing the active substance and the final medicinal product together with

1936-553: Was known as Captain Pepple in trade matters, and King Jubo Jubogha of Opobo , who bore the pseudonym Captain Jaja . Both Pepple and Jaja would bequeath their trade names to their royal descendants as official surnames upon their deaths. In Singapore , there is no filing requirement for a "trading as" name, but there are requirements for disclosure of the underlying business or company's registered name and unique entity number. In

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