Talk:Biopharmaceutical/Archive 1

Archive 1

Material removed from value

sorry wrong entry : Raptiva and Amevive are not anti-TNF alphas.

AMEVIVE® interferes with lymphocyte activation by specifically binding to the lymphocyte antigen, CD2, and inhibiting LFA-3/CD2 interaction.

RAPTIVA binds to CD11a, the subunit of leukocyte function antigen-1 (LFA-1), which is expressed on all leukocytes, and decreases cell surface expression of CD11a. RAPTIVA inhibits the binding of LFA-1 to intercellular adhesion molecule-1 (ICAM-1), thereby inhibiting the adhesion of leukocytes to other cell types. Interaction between LFA-1 and ICAM-1 contributes to the initiation and maintenance of multiple processes, including activation of T lymphocytes, adhesion of T lymphocytes to endothelial cells, and migration of T lymphocytes to sites of inflammation including psoriatic skin.

Source = label information

other wrong entry : biologicals are not mainly used in rhumatoid arthritis. biologicals are growth hormone, insuline, interferons, etc.. used in various indications —Preceding unsigned comment added by Nathanael Bar-Aur L. (talk • contribs) 15:43, 3 May 2006 (UTC)

Abatacept is another biologic that should be added to this list. —Preceding unsigned comment added by 70.91.54.158 (talk • contribs) 15:19, 28 July 2006 (UTC) I have added this to the list, and also made sure that the specification for each agent is correct. RonaldFrits (talk) 23:02, 22 December 2007 (UTC)

Proposed move

I propose that this article be moved, perhaps to biologic medical product, and that biologic should redirect to biology. It's obvious that in this case "biologic" is an abbreviation of a full phrase or phrases, such as biologic therapy, wherein "biologic" is only a descriptor. "Biologic" may be understood to refer to a treatment in a medical context, but in an encyclopedia it's problematic to have the subject at biologic because it's only a subset of the much larger and more widely known field of biology. In order to distinguish linguistically from biology it might at biologics, as it was, but WP:SINGULAR indicates otherwise. So I suggest "biologic X" or "biologic (X)", with the former probably cleaner. ENeville (talk) 19:26, 16 May 2011 (UTC)

I'm not aware of a "full phrase" ever existing; I've always seen references to biologics (i.e., not drugs). If you've got a good source showing that it's an abbreviation, then I have no objection. IMO the best choice is to move it back to the plural. SINGULAR is not an absolute, zero-exceptions rule, and we can use common sense and the explicit "classes of objects" exception to avoid the problem of surprising readers. WhatamIdoing (talk) 04:01, 17 May 2011 (UTC)

A "biologic" is a drug. Furthermore "biologic" is a complete self-contained name that is commonly used to describe "a drug created by a biological process". The phrase "biological product" (see Biological+Products at the U.S. National Library of Medicine Medical Subject Headings (MeSH)) certainly exists and is used, but the abbreviation "biologic" is more commonly used. I would not object to renaming the article "biological product" and redirecting "biologic" to "biological product". However I would very strongly object to redirecting "biologic" to "biology". The later redirect would be extremely confusing and make it difficult for readers to find this article. Boghog (talk) 04:48, 17 May 2011 (UTC)

My concern is that the broadest use, and thus likeliest search, for "biologic" would be in the context of general biology. For those searching for "biologic" in the sense of a biologic medical product, I think the convention would be to have a {{Redirect}} template at the top of biology for "biologic" (similar to the manner of this article currently). It may also be appropriate to send this process to WP:Requested moves, though that can be more decisive with a specific alternate name to compare against. ENeville (talk) 17:55, 18 May 2011 (UTC)

The use of the term "biologics" (see google search) to describe "a drug created by a biological process" is very pervasive. Hence I think it would be better to have a disambiguation page called "biologic" with two or more entries, for example:

Biologic may refer to:

• biology – a process or phenomenon connected with life or living organisms
• biologic medical product – a drug medicinal preparation created by a biological process

Boghog (talk) 03:47, 19 May 2011 (UTC)

That doesn't work for me for two reasons:

1. Most people clicking on biologic really ought to end up at Biology.
2. A biologic is not a drug. Whole blood is a biologic, but it is definitely not a drug. Some therapeutics (e.g., chimeric proteins) are medications created by a biological process, but "drug" is wrong. WhatamIdoing (talk) 04:01, 19 May 2011 (UTC)

In the most common usage, "biologics" is a drug. From the article in most cases, the term "biologics" is used more restrictively for a class of medications that are produced by means of biological processes. This is consistent with the Biological+Products at the U.S. National Library of Medicine Medical Subject Headings (MeSH) definition as "complex pharmaceutical substances". Boghog (talk) 04:20, 19 May 2011 (UTC)

The table in the article contains a list of biologics (mostly anti-inflammatories) that definitely are drugs. Furthermore the linked articles in this table generally contain drugboxes. Boghog (talk) 04:42, 19 May 2011 (UTC)

Medication ≠ Drug. (The term therapeutic is similarly used as a noun that encompasses both drugs and biologics.)

The fact remains that whole blood is a biologic, and that whole blood is not a drug. Don't be led astray by the newest and most expensive forms of biologics; they get a lot of media attention and make investors drool, but they're not the definition of biologics. The meat and potatoes are blood products, childhood and flu vaccines, and allergy shots—none of which are ever called "drugs" by knowledgeable sources. WhatamIdoing (talk) 14:57, 19 May 2011 (UTC)

Of course blood is not a drug. The point I was trying to make is that a sizable subset of biologics are classified as drugs and frequently biologics are equated with drugs (for example this definition: A biologic is a protein-based drug derived from living cells cultured in a laboratory. – National Psoriasis Foundation). Boghog (talk) 15:20, 19 May 2011 (UTC)

If we adopt a somewhat broader definition, the disambiguation page might look like:

• biology – a process or phenomenon connected with life or living organisms
• biologic medical product – a medicinal preparation created by a biological process

Please note that biological (an adjective) already redirects to biology which is reasonable. On the other hand, the search query "biologic" (as a misspelled adjective) might be intended to find biological (and hence biology) whereas "biologic" (as a correctly spelled noun) properly refers to a "biologic medical product". Hence I think it is fair to place these two intended meanings (a malformed query to a more common concept vs. a properly formed query to a less common concept) on a equal footing with a disambiguation page. Boghog (talk) 17:07, 19 May 2011 (UTC)

I agree that people who are ignorant, or who are speaking of one small subset (e.g., the subset of biologics that are relevant to treating psoriasis), or are talking down to the readers, occasionally mislabel biologics as drugs. That doesn't mean that we need to perpetuate their narrow POV and/or errors. The balance of sources, and particularly the balance of high-quality sources, do not conflate biologics with drugs or pretend that proteins produced by recombinant DNA are the be-all and end-all of biologics.

It looks like remarkably few pages mistakenly link here. Perhaps we should just leave it where it is. WhatamIdoing (talk) 18:09, 19 May 2011 (UTC)

I think that "biologic" should be considered a proper spelling for the adjective related to biology. From what I could find, it's at least as old as the 1913 US version of Webster's dictionary, while use of the medical noun is dated to 1921. ENeville (talk) 17:40, 20 May 2011 (UTC)

As a lay-person, a person more used to normal (non-lingo) English usage for medicine and biology than an insider would be, I think "biologic medical product" or "biologically created pharmaceutical" or "biologic pharmaceutical" all make better sense to me as legitimate English terms.

Really, "biologic" for drugs is medical industry insider lingo, lingo based on a kind of abbreviation, an abbreviation only acceptable when in the context of discussion within a specific industry.

In other words, an abbreviation not appropriate outside of that specific industry in a multidisciplinary publication where things other than drugs are discussed.

The form of the word is another clue, it is an *ic, and adjective not a noun.

And my understanding is that lingo should not be used in Wikipedia, except as a cross reference. 50.71.37.239 (talk) 14:53, 18 February 2012 (UTC)

OK, this page has been renamed to biologic medical product with aliases to biological product and biologic. I have also created a biologic disambiguation page that point to both this article and biology. Boghog (talk) 17:54, 18 February 2012 (UTC)

Missing Discussion on Cost of Manufacture

This article is missing discussion of the signficant cost increase to manufacture biologics compared to conventional drugs. This lack of discussion makes the article appear biased when they discuss the increase cost of the product without discussing the increase cost of manufacture and regulatory review (including more data).

Also missing discussion of cost savings argument (or lack thereof) for biosimilars. — Preceding unsigned comment added by 216.2.60.194 (talk) 15:24, 19 August 2011 (UTC)

Should rituximab (Rituxan) be added to the table of biologics?

Should rituximab (Rituxan) be added to the table of biologics? http://en.wikipedia.org/wiki/Rituximab

"Rituximab, sold under the trade names Rituxan and MabThera, is a chimeric monoclonal antibody against the protein CD20, which is primarily found on the surface of B cells. Rituximab is used in the treatment of many lymphomas, leukemias, transplant rejection and some autoimmune disorders." 50.71.37.239 (talk) 14:25, 18 February 2012 (UTC)

merge

today i today i merged Biopharmaceutics into this article, as Biopharmaceutics almost completely overlapped and this article was not so long that it needed a split. In general the "drug" articles are too scattered and lack interconnection. working on fixing that. Jytdog (talk) 21:42, 20 January 2014 (UTC)

@Jytdog - Two comments regarding your merge -

1) I have some expertise and think you are probably right that the two articles should be merged.

2) I think you merged in the wrong direction. My guess is that Biopharmaceutical is the more common name and hence should be the title of this article. NickCT (talk) 22:20, 20 January 2014 (UTC)

Hi NickCT; glad you agree with the merge and happy to discuss the direction. I think you are right that biopharmaceutical is much more common for things like protein therapeutics, but some old school thing like IVIG, not so much. right? that is why i went the other way... Jytdog (talk)

@Jytdog - Re "IVIG" - Maybe. Not overly familiar with the terminology there. What I can say is that the "old school" probably would have hesitated before calling something like small pox vaccine a biopharamceutical.

Found what appears to be a good reference here (though I'm not sure how reliable "BioExecutive International" is). Note how they call out a "broad" definition and "new" definition". I think that's an important distinction. "Biopharmaceutical" is probably a word that meant something slightly different in most circles 20 years ago. Frustratingly it probably means different things when used in different scientific circles today.

My general sense is that the "broad" definition given in BioExec is probably right (i.e. a Biopharmaceutical can be ANY "pharmaceutical manufactured by biotechnology methods, with the products obviously having biological sources, usually involving live organisms or their active components"). I think that would include IVIG?

All this said, I obviously recognize that different people are probably going to have slightly different perspectives on what exactly constitutes a "biopharmaceutical" (again, may depend on scientific circle). Such is nature of advancing sciences I guess.

Shifting definitions makes life on WP fun, no?

My inclination is to move to "biopharmaceutical", then phrase the lead paragraph to try to explain that there multiple definitions. NickCT (talk) 23:30, 20 January 2014 (UTC)

I see! the "broad definition" is pretty much everything regulated by the FDA - both small molecules (what CDER does at the FDA) and protein therapeutics, vaccines, blood products, cell & gene therapies (what [http://www.fda.gov/AboutFDA/CentersOffices/OfficeofMedicalProductsandTobacco/CBER/ucm123340.htm CBER does at the FDA). I was going more by the "new" definition of "biopharmaceutical" - using that to name what are really the products of the biotech industry since the 1990s and and to differentiate those products from what came before. IVIG, by the way, is "intravenous immunoglobulin" - you harvest all the antibodies from blood and give them to someone else as a treatment. It has been done for a long long time and really has nothing to do with biotech per se. Surely biotech technologies are used today in QC or other aspects of making it. Ditto, allergens used in immunotherapy for allergy (where you got to the doctor's office and got shots every week) - the companies that gather antigens and sell them have been doing that forever. But I see how they all smoosh together now and am fine with moving the page the other way. Do you want to do it or shall I? Jytdog (talk) 13:07, 21 January 2014 (UTC)

@Jytdog - re "pretty much everything regulated by the FDA - both small molecules" - Can you explain how small molecules are "pharmaceutical manufactured by biotechnology methods, with the products obviously having biological sources". That doesn't make sense to me. Most small molecules are manufactured by chemical means, and are not from biological sources. Compare and contrast Amoxicillin (made by o-chemists, using organic synthesis, in a beaker) to Trastuzumab (made by biochemists, using genetic engineering, in living expression systems).

re "done for a long long time and really has nothing to do with biotech per se" - Really? Again, speaking from a position of ignorance about IVIG, my understanding of it is that it's usually harvested by apheresis/plasmapheresis. I think one might legitimately call apheresis/plasmapheresis biotech, though viewpoints on that may vary.

re "the companies that gather antigens and sell them have been doing that forever" - Ok. Well, I guess for allergens; there would be a difference between me gathering some peanut dust (not really biotech) and me expressing a peanut allergen in E. coli (definitely biotech).

re "fine with moving the page the other way." - Awesome. I'll give it a crack a bit later. When I move it, I'm going to simultaneously reword the lead to try to capture some of the nuance we've just discussed. NickCT (talk) 20:27, 21 January 2014 (UTC)

ack! I am sorry I am really not this stupid in real life. NOT small molecules, indeed!! i meant everything regulated under CBER and wrote CBER + CDER, which is just nuts. sorry. point taken on IVIG. thanks for taking on the move and for the good discussion. i think that biopharma.com article you found is 100% choice and hope you cite it - rare to find something that perfect on a definitional issue. thanks again! Jytdog (talk) 20:32, 21 January 2014 (UTC)

Inaccurate article

I fundamentally disagree with the content of this article. The definition of biopharmaceutics is:

bi·o·phar·ma·ceu·tics (b-färm-stks) n. The study of the physical and chemical properties of drugs and their proper dosage as related to the onset, duration, and intensity of drug action. This article describes bio pharmaceuticals, not biopharmaceutics. Deaders78 (talk) 06:02, 13 July 2013 (UTC)

Moot. On 2013-07-13, this page was "Talk:Biopharmaceutical". Now, after some move(s), it is "Talk:Biopharmaceutical". Biopharmaceutical discusses biopharmaceuticals, a.k.a. biologic(al) medical products or biologics. (Biopharmaceutics and Biopharmacology redirect here.) Biopharmaceutics is pharmaceutics that works with biopharmaceuticals. Biopharmacology is the branch of pharmacology that studies biopharmaceuticals. - A876 (talk) 05:11, 19 October 2020 (UTC)