Haiku in between the Winter Festivals

Snowflakes are melting

Cold water in the bucket

Wild geese too early

Regular winter

Too warm and no lasting snow

Mossy toboggan

Beneath the snow

Pines and meadows are waiting

Moon on vacation

Clouds drifting white

Snow on the pine trees

Fox in winter

Yellow rim

Grey clouds hanging deep

Hot wine punch

Year after year

A wasted year

By year's end

Biobetters, Biologics, Biosimilars etc.

What are biobetters?  You might ask. Let us recall what other new coined terms we have and then explain what they are.

Biologics are biopharmaceutical products, which we have been using for in rheumatology about two decades now. Biosimilars are somehow generic biologics that may be approved after patent expiry of the original drug. Biosimilars are not completely identical to the original products.

Biobetters are also biosimilars, but they are improved compared to the originator drug. The active part the biobetter may use another protein than the originator drug or use glyco-engineering like pegylation to create a drug that addresses the same target as the originator drug, but its effect on the target may last longer and the risk of immunogenicity may be reduced. A biobetter will be considered a new drug and therefore enjoy market protection.  But the biobetter will have to show new efficacy and safety data, which means the companies will have to invest in lengthy phase 3 studies, which the biosimilars don’t have to do.

Will we hear more about biobetters? I bet yes. Why haven’t we heard about an adalimumab biobetter as Humira’s patent expires? The biobetter would have to compete with four or five biosimilars, which require fewer costs to develop. The real advantage of a biobetter lies in the fact, that it could be launched in the market before the patent on the originator drug expires. If this new concept will have an impact in rheumatology will yet have to be shown.

What are biobetters? Biosimilars, which improve on the originator drugs.

Links:

http://rheumatologe.blogspot.de/2016/08/bioidenticals-biosimilars-biologics.html

https://en.wikipedia.org/wiki/Biosimilar

https://www.financierworldwide.com/competitive-strategies-in-life-sciences-biobetters-versus-biosimilars/#.WF_hLBWmmUk

http://prahs.com/download/whitepapers/The_Value_of_Biobetters.pdf

http://gabi-journal.net/biosimilars-versus-biobetters-a-regulators-perspective.html

https://www.thebalance.com/biobetter-definition-3895896

On sending postcards from Chile

Last year I’ve written about my experiences of sending postcards from Argentina. Argentina fared badly as the clerk at the post office at Terminal A of Ezeiza Airport had sent me from Terminal A to Terminal C to get stamps, but in the meantime he had already and prematurely closed the office.So I’ve sent the postcards from Chile (Viña del Mar) without problems.

You may already have come to the idea that this year something didn’t work as well as last year in Chile. And so it was.

Again I needed stamps for postcards, this time in San Pedro de Atacama. I went to the post office and the guy in front of me just parted. Now it was my turn - or should have been. The clerk greeted me, then took his ringing smartphone and received the call. When ready he called one of his co-workers and told me: “La chica es loca.” I nodded and wanted to tell him, what I really was going to want from him – stamps. But he received another call, made two calls himself, again la chica loca. Already people were queuing up behind me. I still wasn’t annoyed. And then he declared all countries are the same as Alemania, because he didn’t want to type Japan or China on some of the stamps he then printed out. How much did I have to pay? A little too much, just about 0.40 € or two quarters too much. I would have given a tip under two conditions. 1. I decide when to give a tip and how much (it would have been more!). 2. A tip is for good service. This service was lousy.

Back home again, people told me that they hadn’t received their postcards. But the super quick air mail postcards reached Germany and the rest of the world after two months.

What did I learn from this experience? Better send postcards from Viña del Mar, Valparaiso, or Santiago de Chile, not from San Pedro de Atacama.

Link:

On sending postcards from Argentina - http://rheumatologe.blogspot.de/2015/11/on-sending-postcards-from-argentina.html

Risk Reduction of Retinopathy in the Therapy with Chloroquine and Hydroxychloroquine in Rheumatology

Chloroquine (CQ) has been developed for the therapy of malaria. It’s an old drug as the substance had already been discovered in 1934. You might know hydroxychloroquine (HCQ) Plaquenil or Quensyl, which differs from chloroquine just by the presence of a hydroxyl group. We use these antimalarials in rheumatology as DMARD (Disease Modifying Anti Rheumatic Drugs) to treat rheumatoid arthritis (often in combination with methotrexate), systemic lupus erythematodes (SLE), Sjoegren’s syndrome, and others. A study in 1985 found a lower rate of retinopathy in hydroxychloroquine when compared to chloroquine. As retinopathy is not reversible and as there is no present therapy, we need to reduce the risk for the development of antimalarial associated retinopathy.

In June 2016 the American Academy of Ophthalmology published recommendations on screening for chloroquine and hydroxychloroquine retinopathy. They recommend a maximum daily HCQ use of ≤5.0 mg/kg real weight. “The risk of toxicity is dependent on daily dose and duration of use. At recommended doses, the risk of toxicity up to 5 years is under 1% and up to 10 years is under 2%, but it rises to almost 20% after 20 years.” Higher dosage means higher risk, so we have to keep the daily dosage down. Long duration of therapy with antimalarials is another significant risk factor, so we must try to reduce the duration of this therapy. This might be hard to achieve in lupus. Renal disease is another risk factor to look for, but rheumatologists usually screen their patients for renal disease. And we have to look for tamoxifen, as this drug increases the risk for chloroquine and hydroxychloroquine retinopathy. This is sad to hear as the group of patients needing tamoxifen is also the group, where other therapy options like biologicals are contraindicated.

Risk Reduction of Retinopathy:

·         adapted dosage of CQ and HCQ

·         avoiding long duration of therapy

·         screening for renal disease

·         monitoring concomitant medication

·         screening for retinopathy

Links:

https://en.wikipedia.org/wiki/Chloroquine

https://en.wikipedia.org/wiki/Hydroxychloroquine

https://www.ncbi.nlm.nih.gov/pubmed/4057189

https://www.ncbi.nlm.nih.gov/pubmed?term=26992838